MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 UNK BROVIAC REPAIR KIT; PORT AND CATHETER ACCESSORIES

Catalog Number UNK BROVIAC REPAIR KIT

Device Problems Burst Container or Vessel (1074); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2022

Event Type  malfunction  

Event Description

It was reported that some time post repair procedure, the repaired line allegedly torn.There was no reported patient injury.

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.

Event Description

It was reported that some time post repair procedure, the repaired line allegedly torn.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one 9fr broviac d/l catheter was returned for evaluation.Functional, gross visual, and microscopic visual evaluations were performed.A complete circumferential break was noted on the distal end of the catheter.The investigation is confirmed for the reported fracture issue, as a diagonal split was noted on the extension leg, proximal to the clamping sleeve.The surface of the diagonal split on the white luer extension leg were noted to be granular and glossy.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: g3 h11: h6 (method, result, 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.H3 other text : see h10.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one 9fr broviac d/l catheter was returned for evaluation.Functional, gross visual, tactile and microscopic visual evaluations were performed.The investigation is unconfirmed for the reported fracture issue, as no fracture was noted on the returned physical sample.However, the investigation is confirmed for the identified catheter burst issue as a diagonal split was noted on the extension leg, proximal to the clamping sleeve.Furthermore, the break site of the white luer extension leg was noted to be elastically abnormal as tensile weakness was felt.No obstructions were noted throughout 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: 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 Description

It was reported that some time post repair procedure, the repaired line was allegedly torn.There was no reported patient injury.

• Brand Name: UNK BROVIAC REPAIR KIT
• Type of Device: PORT AND CATHETER ACCESSORIES
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15389122
• MDR Text Key: 302684499
• Report Number: 3006260740-2022-03535
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK BROVIAC REPAIR KIT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Sex: Male
• Patient Weight: 24 KG
• Patient Race: White