MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM DOME IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0602870
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: a complaint history review was performed.This is the fourth complaint reported for this lot number and the lot met all release criteria.A device history record review is required.Investigation summary: one titanium dome port, one catheter in two segments, one straight non-coring needle, one right-angle non-coring needle (inserted into the port septum), one guidewire in a guidewire hoop, one introducer peel-apart sheath and vessel dilator, one vessel dilator, one safety infusion set, and one tunneler were returned for evaluation.Visual, microscopic visual, dimensional and functional evaluation were performed.The investigation is confirmed for the identified deformation issue as the dilator tip was found frayed, whereas multiple bends were noted on the guidewire.However, the investigation is inconclusive for the reported failure to advance issue even though a little resistance was experienced while advancing the guidewire through the sheath and dilator, the exact circumstances at the time of the reported event are unknown.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.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.(expiry date: 10/2023).
Event or Problem Description
It was reported that during port placement procedure the device guidewire allegedly failed to advance.There was no reported patient injury.

• Brand Name: TITANIUM DOME IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F
• 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: 12179125
• Report Number: 3006260740-2021-02764
• Device Sequence Number: 2825968
• Product Code: LJT
• UDI-Device Identifier: 00801741025778
• UDI-Public: (01)00801741025778
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K880571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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: 0602870
• Device Catalogue Number: 0602870
• Device Lot Number: RECZ3412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 07/16/2021
• 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