MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN CV CATHETER REPAIR KIT, SINGLE-LUMEN, WHITE, 9.6F; PORT AND CATHETER ACCESSORIES

Model Number	0601630
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one hickman s/l catheter was returned for evaluation.Functional, gross and microscopic visual evaluation were performed.The investigation is confirmed for the reported catheter fracture as a pinhole was observed approximately 4mm from the distal end of the luer.Further during functional evaluation, leak was noted from the pinhole upon infusion and aspiration.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.
Event or Problem Description
It was reported that approximately two months post catheter placement, the catheter was allegedly damaged near the hub.It was further reported that the catheter was clamped near the clamping over sleeve.There was no reported patient injury.

• Brand Name: HICKMAN CV CATHETER REPAIR KIT, SINGLE-LUMEN, WHITE, 9.6F
• Common Device Name: PORT AND CATHETER ACCESSORIES
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12300463
• Report Number: 3006260740-2021-03210
• Device Sequence Number: 11805368
• Product Code: LJS
• UDI-Device Identifier: 00801741036408
• UDI-Public: (01)00801741036408
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K830406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2021

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: 0601630
• Device Catalogue Number: 0601630
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR