MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER, POLYURETHANE, KIT, 14.5F

Model Number	5703690
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the preparation of a port placement procedure, a small hole was allegedly found on the catheter at the cuff.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history record is could be performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H10: (expiry date: 12/2023).H11: section a through f - the information provided by bd represents all of 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.Device not returned.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 19cm hemosplit d/l catheter, one tunneler, one 15fr peel-apart sheath and vessel dilator, one 8fr dilator, one 12fr dilator, two end caps, one introducer needle, one j-tip guidewire in a guidewire hoop and one introducer needle were returned for evaluation.Functional, gross visual, tactile and microscopic visual evaluations were performed.A small pinhole was noted under the tissue cuff and upon infusion, a small leak was noted around the tissue cuff.In addition to the returned physical sample, three electronic photos were provided for review.The photo shows the catheter and a small pinhole was noted under the tissue cuff.Therefore the investigation is confirmed for the reported material puncture/hole issue.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 12/2023), h11: section a through f - the information provided by bd represents all of 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 the preparation of a port placement procedure, a small hole was allegedly found on the catheter at the cuff.The procedure was completed using another device.There was no patient contact.

• Brand Name: HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER, POLYURETHANE, KIT, 14.5F
• 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: 17169259
• Report Number: 3006260740-2023-02533
• Device Sequence Number: 15220170
• Product Code: MSD
• UDI-Device Identifier: 00801741012884
• UDI-Public: (01)00801741012884
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2023

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 Model Number: 5703690
• Device Catalogue Number: 5703690
• Device Lot Number: REGP0438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2022
• 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