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 Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 03/2023).
Event or Problem Description
It was reported that during a procedure, the catheter was allegedly broken.It was further reported that blood leak occurred.There was no reported patient injury.
Event or Problem Description
It was reported that during a procedure, the catheter was allegedly broken.It was further reported that blood leak occurred.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation, however one photo was provided for review.The investigation is confirmed for the reported fluid leak issue as blood leakage was found on the catheter just distal to the bifurcation.However, the investigation is inconclusive for the reported fracture as the provided photo itself is not clear enough to confirm the issue.A definitive root cause could not be determined based upon the 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: b5, d4 (expiry date: 03/2023).H11: 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.H3 other text : device not returned.

• 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
• MDR Report Key: 12444951
• Report Number: 3006260740-2021-03724
• Device Sequence Number: 17039505
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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: REEW1673
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1