MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HEMOSTAR; DIALYSIS CATHETER

Catalog Number	5833730
Medical Device Problem Codes	Suction Problem (2170); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.However, a video was provided for review.The investigation of the reported event is currently underway.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
On (b)(6) 2025, a 71-year-old male patient was undergoing a dialysis catheter placement using hemostar.During the procedure, introducer needle allegedly leaked air when placing a long-term tubing for dialysis, and a full set of tubing was replaced for the procedure.
Event or Problem Description
On (b)(6) 2025, a 71-year-old male patient was undergoing a dialysis catheter placement using hemostar.During the procedure, the introducer the needle was allegedly found air leak.It was further reported that needle was allegedly found that it cannot be suction liquid.There was no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.However, a video was provided for review.The investigation of the reported event is currently underway.B5, d4 (medical device lot #, medical device expiration date, unique identifier (udi) #), e1, g3, h6 (device, method).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
On (b)(6) 2025, a 71-year-old male patient was undergoing a dialysis catheter placement using hemostar.During the procedure, the introducer the needle was allegedly found air leak.It was further reported that needle was allegedly found that it cannot be suction liquid.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation; one video was provided for review.The video shows an ot setup tray placed with a steel container containing some transparent liquid with the catheter into it.Tunneler , guidewire in a guidewire hoop, scissors and sheath are placed alongside the steel container.A physician is seen to attempt to withdraw the transparent liquid with the needle, but no liquid is seen in the syringe.At the end of video, physician removes the needle from syringe.Therefore, the investigation is confirmed for the reported suction issue.However, it is inconclusive for the reported patient had an air leak from the introducer needle when placing a long-term tubing for dialysis, as the video evidence provided is not sufficient to confirm the reported event.A guidewire was returned for evaluation but no allegation for any guidewire defect /issue reported.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D4 (unique identifier (udi) #), g3, h6 (method, result, conclusion) section a through f: the information provide 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
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation; one video was provided for review.The video (b)(4) shows an ot setup tray placed with a steel container containing some transparent liquid with the catheter into it.Tunneler, guidewire in a guidewire hoop, scissors and sheath are placed alongside the steel container.A physician is seen to attempt to withdraw the transparent liquid with the needle, but no liquid is seen in the syringe.At the end of video, physician removes the needle from syringe.Therefore, the investigation is confirmed for the reported suction issue.However, it is inconclusive for the reported patient had an air leak from the introducer needle when placing a long-term tubing for dialysis, as the video evidence provided is not sufficient to confirm the reported event.A guidewire was returned for evaluation but no allegation for any guidewire defect /issue reported.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G3, h6 (method).Section a through f: the information provide 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
On (b)(6) 2025, a 71-year-old male patient was undergoing a dialysis catheter placement using hemostar.During the procedure, the introducer the needle was allegedly found air leak.It was further reported that needle was allegedly found that it cannot be suction liquid.There was no reported patient injury.

• Brand Name: HEMOSTAR
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 22628497
• Report Number: 3006260740-2025-05235
• Device Sequence Number: 7989622
• Product Code: MSD
• UDI-Device Identifier: 00801741013409
• UDI-Public: (01)00801741013409(11)240518(17)260331(10)REJR0844
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/13/2025

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: 03/31/2026
• Device Catalogue Number: 5833730
• Device Lot Number: REJS0844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 08/11/2025; 10/06/2025; 11/13/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 09/08/2025; 10/08/2025; 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2024
• 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
• Patient Sex: Unknown