MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PROXIS¿ URETERAL ACCESS SHEATH

Catalog Number	231045
Medical Device Problem Codes	Nonstandard Device (1420); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before use, access sheath could not be used due to foreign substances found in the middle part.Lot# bmjrfm31, lot# bmjqfm25.Per follow up information received via ibc on 09apr2025, stated that there were two defective products were found in lot# bmjrfm31 and lot# bmjqfm25.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that before use, access sheath could not be used due to foreign substances found in the middle part.Lot #bmjrfm31, lot #bmjqfm25.Per follow up information received via ibc on 09apr2025, stated that there were two defective products were found in lot #bmjrfm31 and lot #bmjqfm25.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation noted received 1 ureteral access sheath.Verified material number 231045 and batch number bmjrfm31.Visual inspection noted foreign material on the access sheath.Also received 3 photo samples.First and second photo sample shows top view of product packaging indicating lot number product material number.Third photo sample shows top view of access sheath and dilator with unknown material present on access sheath.Based on the photo sample received the reported event is confirmed.No additional actions are required at this time since root cause was not identified.A dhr review did not show any problems or conditions that would have contributed to the reported event.The instructions for use were found adequate and state the following: ¿indications for use: the proxis¿ ureteral access sheath is indicated for use in endoscopic urology procedures where ureteral dilation and ureteral access is desired for injection of fluids and insertion and removal of endoscopes and related instruments.Warning: for single use only.Do not reuse, reprocess or resterilize.Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/ or lead to device failure, which in turn, may result in patient injury, illness or death.Reuse reprocessing or re-sterilization may also create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.Contamination of the device may lead to injury, illness or death of the patient.Do not use if sterile barrier is damaged.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and with applicable laws and regulations.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Precautions: the recommendations given are meant to serve only as a basic guide to the utilization of this access sheath.The ureteral access sheath should not be used without comprehensive knowledge of the indications, techniques and risks of the procedure.To minimize resistance during advancement, ensure the hydrophilic coating on the dilator and sheath is activated with saline or sterile water prior to placement.Do not advance sheath without the dilator in place as this could lead to trauma or injury to patient.Do not bend the device prior to placement as this could damage the integrity of the device and result in patient injury.Do not advance or withdraw device if any resistance is encountered during placement or removal without determining cause and taking action.Adverse events: potential adverse events associated with the use of the transurethral access device include, but are not limited to: - mucosal irritation, inflammation and edema - urethral strictures - acute bleeding or hemorrhage - urethral, bladder, or ureteral perforation - other injury to the urinary tract¿ correction: d, h.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d, f, h.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that before use, access sheath could not be used due to foreign substances found in the middle part.Lot #bmjrfm31, lot #bmjqfm25.Per follow up information received via ibc on 09apr2025, stated that there were two defective products were found in lot #bmjrfm31 and lot #bmjqfm25.
Event or Problem Description
It was reported that before use, access sheath could not be used due to foreign substances found in the middle part.Lot#bmjrfm3, lot#bmjqfm25.Per follow up information received via ibc on 09apr2025, stated that there were two defective products were found in lot#bmjrfm31 and lot#bmjqfm25.
Additional Manufacturer Narrative
The reported event is confirmed due to the supplier.Visual: the sample was provided with the original sleeve and placed inside a large ziploc bag.The complaint indicated that foreign matter was discovered during product placement.The recovered matter taped to the exterior to a point in the process where samples were removed from the cooling rack before they had fully cooled, leading to the unintentional transfer of adhesive.The issue was identified during in-process monitoring, and corrective actions were implemented to prevent recurrence.However, it is important to note that the corrective measures were instituted after the release of the lot referenced in this report.No actions can be taken at this time since a root cause was not identified.Dhr review did not show any problems or conditions that would have contributed to the reported event.The instructions for use were found adequate and state the following: indications for use: the proxis ureteral access sheath is indicated for use in endoscopic urology procedures where ureteral dilation and ureteral access is desired for injection of fluids and insertion and removal of endoscopes and related instruments.Contraindications: patients who are contraindicated for retrograde urological procedures.Patients who are contraindicated for antegrade urologic procedures, including but not limited to patients with blood clotting anomalies due to coagulopathies or pharmacological anticoagulation.Patients who have the presence of tight strictures which would limit use of the device.Patients who have the presence of large obstructing distal ureteral calculi.Warning: for single use only.Do not reuse, reprocess or resterilize.Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/ or lead to device failure, which in turn, may result in patient injury, illness or death.Reuse reprocessing or re-sterilization may also create a risk of contamination of the device and/or cause patient infection or crossinfection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.Contamination of the device may lead to injury, illness or death of the patient.Do not use if sterile barrier is damaged.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and with applicable laws and regulations.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Precautions: the recommendations given are meant to serve only as a basic guide to the utilization of this access sheath.The ureteral access sheath should not be used without comprehensive knowledge of the indications, techniques and risks of the procedure.To minimize resistance during advancement, ensure the hydrophilic coating on the dilator and sheath is activated with saline or sterile water prior to placement.Do not advance sheath without the dilator in place as this could lead to trauma or injury to patient.Do not bend the device prior to placement as this could damage the integrity of the device and result in patient injury.Do not advance or withdraw device if any resistance is encountered during placement or removal without determining cause and taking action.Adverse events potential adverse events associated with the use of the transurethral access device include, but are not limited to: mucosal irritation, inflammation and edema urethral strictures acute bleeding or hemorrhage urethral, bladder, or ureteral perforation other injury to the urinary tract directions for use: 1.Activate the hydrophilic coating by placing the dilator and sheath components into saline or sterile water.Place an 0.035 (0.889mm) or 0.038" (0.965mm) guidewire into the ureter using standard endourology techniques.2.Ensure the dilator lock is securely engaged with sheath hub prior to insertion.3.Insert the guidewire into the tapered end of the dilator/sheath assembly and gradually advance the assembly into the ureter.Note: placement of the assembly can be verified using fluoroscopy or radiographic means.4.While maintaining sheath position, disengage the dilator lock from the sheath hub to gently remove the dilator.Do not advance sheath without the dilator in place.Note: suture holes are provided on sheath hub for securing externally, if desired.5.An endoscope and/or related instruments can now be used through the ureteral sheath as needed.6.If desired, irrigation can be applied using the luer connector on the dilator.7.Upon completion of the access procedure, gently withdraw the device.8.Discard the device in accordance with hospital procedures and with applicable laws and regulations.For urological use only correction: h.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that before use, access sheath could not be used due to foreign substances found in the middle part.Lot#bmjrfm31, lot#bmjqfm25.Per follow up information received via ibc on (b)(6) 2025, stated that there were two defective products were found in lot#bmjrfm31 and lot#bmjqfm25.
Additional Manufacturer Narrative
The reported event is confirmed due to the supplier.Visual: the sample was provided with the original sleeve and placed inside a large ziploc bag.The complaint indicated that foreign matter was discovered during product placement.The recovered matter taped to the exterior to a point in the process where samples were removed from the cooling rack before they had fully cooled, leading to the unintentional transfer of adhesive.The issue was identified during in-process monitoring, and corrective actions were implemented to prevent recurrence.However, it is important to note that the corrective measures were instituted after the release of the lot referenced in this report.Also received 3 photo samples.First and second photo sample shows top view of product packaging indicating lot number product material number.Third photo sample shows top view of access sheath and dilator with unknown material present on access sheath.Based on the supplier report received the reported event is confirmed.No actions can be taken at this time since a root cause was not identified.Dhr review did not show any problems or conditions that would have contributed to the reported event.The instructions for use were found adequate and state the following: indications for use: the proxis ureteral access sheath is indicated for use in endoscopic urology procedures where ureteral dilation and ureteral access is desired for injection of fluids and insertion and removal of endoscopes and related instruments.Contraindications: patients who are contraindicated for retrograde urological procedures.Patients who are contraindicated for antegrade urologic procedures, including but not limited to patients with blood clotting anomalies due to coagulopathies or pharmacological anticoagulation's.Patients who have the presence of tight strictures which would limit use of the device.Patients who have the presence of large obstructing distal ureteral calculi.Warning: for single use only.Do not reuse, reprocess or resterilize.Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/ or lead to device failure, which in turn, may result in patient injury, illness or death.Reuse reprocessing or re-sterilization may also create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.Contamination of the device may lead to injury, illness or death of the patient.Do not use if sterile barrier is damaged.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and with applicable laws and regulations.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Precautions: the recommendations given are meant to serve only as a basic guide to the utilization of this access sheath.The ureteral access sheath should not be used without comprehensive knowledge of the indications, techniques and risks of the procedure.To minimize resistance during advancement, ensure the hydrophilic coating on the dilator and sheath is activated with saline or sterile water prior to placement.Do not advance sheath without the dilator in place as this could lead to trauma or injury to patient.Do not bend the device prior to placement as this could damage the integrity of the device and result in patient injury.Do not advance or withdraw device if any resistance is encountered during placement or removal without determining cause and taking action.Adverse events potential adverse events associated with the use of the transurethral access device include, but are not limited to: mucosal irritation, inflammation and edema urethral strictures acute bleeding or hemorrhage urethral, bladder, or ureteral perforation other injury to the urinary tract directions for use: 1.Activate the hydrophilic coating by placing the dilator and sheath components into saline or sterile water.Place an 0.035 (0.889mm) or 0.038" (0.965mm) guidewire into the ureter using standard endourology techniques.2.Ensure the dilator lock is securely engaged with sheath hub prior to insertion.3.Insert the guidewire into the tapered end of the dilator/sheath assembly and gradually advance the assembly into the ureter.Note: placement of the assembly can be verified using fluoroscopy or radiographic means.4.While maintaining sheath position, disengage the dilator lock from the sheath hub to gently remove the dilator.Do not advance sheath without the dilator in place.Note: suture holes are provided on sheath hub for securing externally, if desired.5.An endoscope and/or related instruments can now be used through the ureteral sheath as needed.6.If desired, irrigation can be applied using the luer connector on the dilator.7.Upon completion of the access procedure, gently withdraw the device.8.Discard the device in accordance with hospital procedures and with applicable laws and regulations.For urological use only correction: d, h udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: PROXIS¿ URETERAL ACCESS SHEATH
• Common Device Name: URETERAL ACCESS SHEATH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 21832648
• Report Number: 1018233-2025-02638
• Device Sequence Number: 4223848
• Product Code: FED
• UDI-Device Identifier: 00801741101694
• UDI-Public: (01)00801741101694(11)240520(17)270418(10)BMJRFM31
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K160861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 231045
• Device Lot Number: BMJRFM31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Supplement Date Received by Manufacturer: 06/18/2025; 07/09/2025; 07/14/2025; 07/22/2025
• Initial Report FDA Received Date: 04/14/2025
• Supplement Report FDA Received Date: 06/20/2025; 07/10/2025; 07/16/2025; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown