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

Catalog Number	231035
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	05/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 during use, there was foreign matter like resin pieces that were mixed in the dilator catheter.Per follow up information received via ibc on 13jun2024, confirmed that the resin piece was present inside the dilator.
Event or Problem Description
It was reported that during use, there was foreign matter like resin pieces that were mixed in the dilator catheter.Per follow up information received via ibc on 13jun2024, confirmed that the resin piece was present inside the dilator.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation noted the sample was provided with the original bard pouch and a clear tube with the lid inside a large ziploc bag.Visual inspection per (b)(4) state to use unaided eye at 12 to 18 distance under normal room lighting.Upon analyzing the sample, it was evident it has been previously used, as indicated by the presence of dry blood and bodily fluids.The provided tube was intended to contain the foreign matter, but the lid had come off during shipping, making it impossible to locate the foreign matter itself.A photograph of the foreign matter was available prior to the sample's arrival at biomerics.The matter depicted in the photo resembles the material used in the making of the sheath.The sample looks similar to what is seen when an object is inserted an shaved on the side of the sheath.Also received 4 photo samples.First photo sample shows top view of dilator inserted within sheath and a collection tube.Second and third photo samples zoom in on site of foreign material present.Fourth photo sample shows product packaging.Based on the photo and physical sample received the reported event is confirmed.Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be storage or handling contamination (solvents, surfactants).Dhr review did not show any problems or conditions that would have contributed to the reported event.Labelling review is not required.Correction: d 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 reported event is confirmed cause unknown.Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be storage or handling contamination (solvents, surfactants).However, there was insufficient information to confirm this potential root cause.Visual evaluation noted the sample was provided with the original bard pouch and a clear tube with the lid inside a large ziploc bag.Visual inspection per (b)(4) state to use unaided eye at 12" to 18" distance under normal room lighting.Upon analyzing the sample, it was evident it has been previously used, as indicated by the presence of dry blood and bodily fluids.The provided tube was intended to contain the foreign matter, but the lid had come off during shipping, making it impossible to locate the foreign matter itself.A photograph of the foreign matter was available prior to the sample's arrival at biomerics.The matter depicted in the photo resembles the material used in the making of the sheath.The sample looks similar to what is seen when an object is inserted an shaved on the side of the sheath.Dhr review did not show any problems or conditions that would have contributed to the reported event.Labelling review is not required as labelling would not have prevented the reported event.Correction: d, e, 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 during use, there was foreign matter like resin pieces that were mixed in the dilator catheter.Per follow up information received via ibc on 13jun2024, confirmed that the resin piece was present inside the dilator.
Event or Problem Description
It was reported that during use, there was foreign matter like resin pieces that were mixed in the dilator catheter.Per follow up information received via ibc on (b)(6) 2024, confirmed that the resin piece was present inside the dilator.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d, e, 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.

• 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, GA 30014 ; 7707846100
• MDR Report Key: 19547055
• Report Number: 1018233-2024-03505
• Device Sequence Number: 17356347
• Product Code: FED
• UDI-Device Identifier: 00801741101687
• UDI-Public: (01)00801741101687(11)230208(17)260126(10)BMHNFM24
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/23/2025

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 Expiration Date: 01/26/2026
• Device Catalogue Number: 231035
• Device Lot Number: BMHNFM24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 08/29/2024; 07/14/2025; 07/23/2025
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 08/30/2024; 07/16/2025; 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• 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