MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BROVIAC CV CATHETER REPAIR KIT, SINGLE-LUMEN, WHITE, 6.6F; PORT AND CATHETER ACCESSORIES

Model Number	0601620
Medical Device Problem Codes	Fluid/Blood Leak (1250); Reflux within Device (1522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history record will not be performed.The return of sample is pending.However, a photo is provided for a review.The investigation of the reported event is currently underway.Device pending return.
Event or Problem Description
It was reported that post procedure, the device allegedly malfunctioned.There was no reported patient injury.
Event or Problem Description
It was reported that post procedure, the user allegedly identified blood in the repair joints after the catheter was repaired.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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 repair catheter was returned for evaluation and one electronic photo was provided for review.Visual and functional evaluation were performed on the returned device.The investigation is inconclusive for the reported reflux within the device as the exact circumstances at the time of the reported event are unknown, and the reported event could not be reproduced in the lab.However, the investigation is confirmed for the reported blood leak issue as blood was noted to be leaking from the joint of the repair segment inside the sleeve.A definitive root cause could not be determined.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.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.

• Brand Name: BROVIAC CV CATHETER REPAIR KIT, SINGLE-LUMEN, WHITE, 6.6F
• 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: 10783178
• Report Number: 3006260740-2020-20357
• Device Sequence Number: 3799159
• Product Code: LJS
• UDI-Device Identifier: 00801741074479
• UDI-Public: (01)00801741074479
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K830406
• 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): 02/10/2021

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: 0601620
• Device Catalogue Number: 0601620
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other