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

Model Number 0600520

Device Problems Fracture (1260); Deformation Due to Compressive Stress (2889); Expulsion (2933)

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

Event Date 12/26/2022

Event Type  malfunction  

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 sometime post chronic catheter placement, the catheter was allegedly expulsed.It was further reported that, the device was removed.There was no reported patient injury.

Event Description

It was reported that sometime post chronic catheter placement, the patient pulled out the catheter and the device was allegedly expelled.It was further reported that, the device was removed.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 broviac s/l catheter was returned for evaluation.Gross, microscopic visual, functional testing and tactile evaluation were performed.Splits were noted on the strengthening sheath and on the catheter tube.Twisting and bunching was observed throughout the strengthening sheath.A complete circumferential break was noted on the distal end of the catheter and the edges of the complete circumferential break were noted to be uneven.Also the portion of the distal end was noted to be missing.Therefore the investigation is confirmed for the identified fracture and deformation issues.However, the investigation is inconclusive for the reported catheter expulsion as the exact circumstances at the time of the reported event are unknown.The definitive root cause could not be determined based upon 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, h6 (device).H11: b5, 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.

• Brand Name: BROVIAC CV CATHETER, SINGLE-LUMEN, 4.2F
• Type of Device: CHRONIC CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16238944
• MDR Text Key: 308096609
• Report Number: 3006260740-2023-00111
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741051807
• UDI-Public: (01)00801741051807
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K830256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2023

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
• Device Operator: Health Professional
• Device Model Number: 0600520
• Device Catalogue Number: 0600520
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2022
• Initial Date FDA Received: 01/25/2023
• Supplement Dates Manufacturer Received: 04/12/2023
• Supplement Dates FDA Received: 04/18/2023
• 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: 1 YR