MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BROVIAC CV CATHETER REPAIR KIT, SINGLE-LUMEN, WHITE, 4.2F; PORT AND CATHETER ACCESSORIES

Model Number	0601610
Medical Device Problem Codes	Burst Container or Vessel (1074); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one broviac s/l catheter was returned for evaluation.Gross visual and microscopic observation, functional testing and tactile evaluation were performed.The investigation is confirmed for the reported catheter fracture and identified burst issues as crescent-shaped partial break was observed on the repair catheter which is consistent with burst.The edges of the partial break was smooth.Further during functional evaluation leakage was noted from the partial break upon infusion and air was aspirated upon 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 six months post catheter placement, the repair kit allegedly damaged.There was no reported patient injury.

• Brand Name: BROVIAC CV CATHETER REPAIR KIT, SINGLE-LUMEN, WHITE, 4.2F
• 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: 12390220
• Report Number: 3006260740-2021-03605
• Device Sequence Number: 4119536
• Product Code: LJS
• UDI-Device Identifier: 00801741036385
• UDI-Public: (01)00801741036385
• 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): 08/09/2021

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: 0601610
• Device Catalogue Number: 0601610
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1