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

Model Number	0601610
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
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 return of the sample is pending.The investigation of the reported event is currently underway.Expiry date: 08/2022.
Event or Problem Description
It was reported that during the catheter placement, the device allegedly cracked.There was no reported patient injury.
Event or Problem Description
It was reported that during the catheter placement, the two repair sheaths allegedly cracked.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the fourth complaint reported for this lot number and the lot met all release criteria.A device history record review is required.Investigation summary: the device was not returned for evaluation.Therefore, the reported fracture issue cannot be confirmed.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: d4 (expiry date: 08/2022), g3, h6 (method).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.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one broviac s/l catheter repair kit was returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.A complete circumferential break was noted approximately 0.7 cm from the distal end of the repair kit.However, striations were noted on the surface of the complete circumferential break.The investigation is confirmed for the reported repair sheath fracture issue, as a longitudinal split was noted approximately 0.2 cm distal to the protective clamping sleeve.The longitudinal split surface was observed to be smooth.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.D4 (expiry date: 08/2022).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.
Event or Problem Description
It was reported that during the catheter placement, the two repair sheaths allegedly cracked.There was no reported patient injury.

• Brand Name: BROVIAC CV CATHETER REPAIR KIT, SINGLE-LUMEN, WHITE, 4.2F
• Common Device Name: CHRONIC CATHETERS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12006262
• Report Number: 3006260740-2021-02297
• Device Sequence Number: 16970084
• Product Code: LJS
• UDI-Device Identifier: 00801741036385
• UDI-Public: (01)00801741036385
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2021

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: REEW3207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 07/27/2021; 09/13/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 07/28/2021; 09/15/2021
• 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