MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BROVIAC CV CATHETER, SINGLE-LUMEN, 6.6F; CHRONIC CATHETERS

Catalog Number	0600540
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316); Difficult to Remove (1528); Material Separation (1562); Stretched (1601); Unraveled Material (1664); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Material Integrity Problem (2978); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a chronic catheter placement procedure, when the guidewire was inserted, resistance was allegedly felt and the guidewire was allegedly difficult to be advanced.It was further reported that the guidewire was allegedly difficult to be removed.Furthermore, when pulled back, the guidewire was allegedly found to be damaged.The procedure was completed by using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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.H10: d4 (expiration date: 09/2027).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
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 j-tip guidewire in two segments and one introducer needle was received for evaluation.Visual, microscopic and dimensional evaluations were performed.The distal j-tip of the guidewire appeared detached from the guidewire and was returned.The proximal end of the j-tip segment appeared uncoiled.Under microscope observation a break was noted at the distal end of the guidewire.A round core wire was noted to be protruding from the proximal end of the j-tip distal segment.Therefore, the investigation is confirmed for the reported material integrity and identified fracture, material separation, stretched and unraveled issues.However, the investigation is inconclusive for the reported physical resistance, difficult to advance and difficult to remove issues as the functional testing cannot be performed in the lab due to the condition of the sample.Also, the investigation is confirmed for the identified improper procedure or method used issue as only the guidewire was removed while the needle was held still.A definitive root cause could not be determined based upon the provided 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.The instructions for use states: cautions: if the guidewire must be withdrawn while the needle is inserted, remove both the needle and guidewire as a unit to help prevent the needle from damaging or shearing the guidewire.H10: d4 (expiration date: 09/2027), g3, h6 (device) h11: h6 (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.
Event or Problem Description
It was reported that during a chronic catheter placement procedure, when the guidewire was inserted, resistance was allegedly felt, and the guidewire was allegedly difficult to be advanced.It was further reported that the guidewire was allegedly difficult to be removed.Furthermore, when pulled back, the guidewire was allegedly found to be damaged.The procedure was completed by using another device.There was no reported patient injury.

• Brand Name: BROVIAC CV CATHETER, SINGLE-LUMEN, 6.6F
• 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: 19228261
• Report Number: 3006260740-2024-02025
• Device Sequence Number: 6892031
• Product Code: LJS
• UDI-Device Identifier: 00801741051821
• UDI-Public: (01)00801741051821
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K830256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2024

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 Catalogue Number: 0600540
• Device Lot Number: HUHU0772
• 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: 04/08/2024
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 06/07/2024
• 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 Sex: Unknown