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

Catalog Number 0602680

Device Problems Improper or Incorrect Procedure or Method (2017); Defective Component (2292); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907); Difficult to Advance (2920)

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

Event Date 10/19/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 07/2026).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 Description

It was reported that during a port placement procedure, the diameter of the dilator was allegedly smaller than the catheter.It was further reported that the catheter was allegedly difficult to be advanced.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one bardport mri implantable port kit was returned for evaluation.Visual, microscopic, functional and dimensional evaluations were performed on the returned device.The edges of the distal tip of the vessel dilator were noted to be jagged and deformed.Therefore the investigation is inconclusive for the reported difficult to advance and detachment issue as the exact circumstance at the time of the event reported was unknown.However the investigation is unconfirmed for the reported defective component issue as the dimensional observation was noted to be within the limits.The investigation is confirmed for the identified improper or incorrect procedure or method as the placement was noted to be against the instructions for use.The investigation is also confirmed for the identified dilator deformation issue.The definitive root cause for the reported defective component, difficulty in progression of the catheter, detachment and the identified deformation issues could not be determined based upon available information.Also, the root cause for the identified improper or incorrect procedure or method was due to the user error.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 instruction for use was reviewed and states that : peel-apart sheath introducer instructions: 2.Release the locking mechanism and gently withdraw the vessel dilator and ¿j¿ wire, leaving the sheath in place.3.Insert catheter into the sheath.Advance the catheter through the sheath into the vessel to the desired infusion site.D4 (expiry date: 07/2026), g3, h6 (device) (method, result, conclusion) 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 Description

It was reported that during a port placement procedure, the diameter of the dilator was allegedly smaller than the catheter.It was further reported that the catheter was allegedly difficult to be advanced.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: M.R.I. IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18325337
• MDR Text Key: 330488714
• Report Number: 3006260740-2023-05709
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K873213
• 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: 02/02/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 0602680
• Device Lot Number: REGV2629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2022
• 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