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

Model Number	0600060
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Disconnection (1171); Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
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.(expiration date: 09/2027).
Event or Problem Description
It was reported that less than twenty-four hours after chronic catheter insertion, the outer tube allegedly became disconnected from the inner tube at the juncture of the two-tube section with the ¿clamp here¿ section.It was further reported that the device was repaired successfully.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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 was returned for evaluation.Gross, microscopic visual, tactile evaluation and functional testing were performed.In addition to the returned physical sample, two electronic photos were provided for review and the photo shows one broviac catheter implanted in a patient.In visual evaluation, the outer catheter tube was noted to be disconnected from the inner tube and a complete circumferential break was noted on the proximal end of the outer catheter tube.Lack of adhesive was noted on the distal end of the clamping sleeve and the inner catheter.Therefore, the investigation is confirmed for the reported catheter fracture and identified loss or failure to bond and material separation issues.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: d4 (expiration date: 09/2027), g3 h11: b5, h6 (device, method, result, conclusion) h11: section a through f ¿ the information provided 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.H3 other text : see h10.
Event or Problem Description
It was reported that one day post catheter placement, the outer tube allegedly became disconnected from the inner tube at the juncture of the two-tube section.It was further reported that the device was repaired.There was no reported patient injury.

• Brand Name: BROVIAC CV CATHETER, SINGLE-LUMEN, 4.2F
• Common Device Name: CHRONIC CATHETERS
• 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: 16658698
• Report Number: 3006260740-2023-01094
• Device Sequence Number: 20642339
• Product Code: LJS
• UDI-Device Identifier: 00801741051692
• UDI-Public: (01)00801741051692
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K830256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2023

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
• Operator of Device: Health Professional
• Device Model Number: 0600060
• Device Catalogue Number: 0600060
• Device Lot Number: HUGW0953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Sex: Male