MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BROVIAC CV CATHETER REPAIR KIT, SINGLE-LUMEN, WHITE, 4.2F; CHRONIC CATHETER REPAIR

Model Number	0600524
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); Blood Loss (2597)
Date of Event	04/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Expiry date (01/2022).
Event or Problem Description
It was reported that approximately three months post chronic catheter placement, the catheter allegedly broke externally.It was further reported that the patient experienced bleeding from the broken catheter.The chronic catheter was removed and replaced.The patient status is unknown post replacement.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review, a dhr review, and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one broviac repair catheter was returned for evaluation.Visual and functional evaluation were performed on the returned device.The investigation is confirmed for catheter break as a longitudinal split was observed on the distal end of the catheter.Both inner and outer catheter lumen had a circumferential break.Further the investigation is confirmed for suction issue since an unsuccessful attempt was made aspirating the catheter.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.H11: d1, d4, h6 (patient, device, method, result and conclusion).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 approximately three months post chronic catheter placement, the catheter allegedly broke externally.It was further reported that the patient experienced bleeding from the broken catheter.The chronic catheter was removed and replaced.The patient status is unknown post replacement.

• Brand Name: BROVIAC CV CATHETER REPAIR KIT, SINGLE-LUMEN, WHITE, 4.2F
• Common Device Name: CHRONIC CATHETER REPAIR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10172764
• Report Number: 3006260740-2020-02107
• Device Sequence Number: 2405352
• Product Code: LJS
• UDI-Device Identifier: 00801741051814
• UDI-Public: (01)00801741051814
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K830406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0600524
• Device Catalogue Number: 0601610
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Initial Date Received by Manufacturer: 05/31/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 11/12/2020
• 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: Required Intervention
• Patient Weight: 5