MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM LOW-PROFILE IMPLANTABLE PORT, BROVIAC SINGLE-LUMEN, 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0602190
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 11/2024).
Event or Problem Description
It was reported that during a port placement procedure, the guidewire was allegedly frayed and lodged in the introducer needle.It was further reported that the device was difficult to be advanced or removed.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during a port placement procedure, the guidewire was allegedly frayed and lodged in the introducer needle.It was further reported that the device was difficult to be advanced or removed.The procedure was completed using another device.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 introducer needle within protective tubing and a guidewire was returned for evaluation and one electronic photo was provided for review.Functional, gross and microscopic visual evaluation were performed.Unravelling of guidewire was noted near the distal end of the guidewire.A bend was noted on the guidewire distal to the guidewire unravelling.The flat inner core wire was observed protruding from the outer coil of the guidewire and a complete circumferential break was noted.The investigation is confirmed for the reported fracture, deformation issue and identified stretched issue.However, the investigation is inconclusive for the reported difficult to remove and advance as the exact circumstances at the time of the reported event are unknown and could not be evaluated due to the nature of the sample condition.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: 11/2024).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.H3 other text : see h10.

• Brand Name: TITANIUM LOW-PROFILE IMPLANTABLE PORT, BROVIAC SINGLE-LUMEN, 6.6F
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12097871
• Report Number: 3006260740-2021-02512
• Device Sequence Number: 3713275
• Product Code: LJT
• UDI-Device Identifier: 00801741025549
• UDI-Public: (01)00801741025549
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2021

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: 0602190
• Device Catalogue Number: 0602190
• Device Lot Number: REEQ2755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 09/21/2021
• 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