MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. HARD BASE IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 0604580

Device Problems Fracture (1260); Material Puncture/Hole (1504); Suction Problem (2170); Obstruction of Flow (2423)

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

Event Date 12/30/2022

Event Type  malfunction  

Event Description

It was reported that prior to a port placement procedure, the port allegedly had suction issue.It was further reported that the port allegedly had obstruction of flow.The procedure was completed by using another device.There was no patient contact.

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 07/2026).

Event Description

It was reported that prior to a port placement procedure, the port allegedly had suction issue.It was further reported that port allegedly had a hole in needle.The procedure was completed by using another device.There was no patient contact.

Manufacturer Narrative

H10: 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 powerport implantable kit.Following components were received: one catheter, one introducer needle, one 7.0fr peel-apart sheath and a vessel dilator, one cath-lock loaded with a catheter segment, one vein pick, one right-angle and one straight non-coring needle, one flushing connector, one j-tip guidewire, one guidewire hoop and one tunneler was returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.In addition to the returned physical sample, one electronic photo was provided for review.The investigation is confirmed for the identified fracture issue as cracks were noted throughout the introducer needle hub and upon infusion, leaks from the hub were observed while water exited the distal end of the introducer needle.Manufacturing site evaluation found out that it was observed that in the proximal part of the hub there were translucent lines that appeared to be cracks, it was observed that the cavity that presented the cracks was number four.The cracks that were in the needle hub caused a leak through the hub.However, the investigation is inconclusive for the reported suction problem and material puncture issues, as the exact circumstances at the time of the reported event cannot be verified, and the reported event could not be reproduced in the lab.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 (expiry date: 07/2026).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.H3 other text : see h10.

• Brand Name: M.R.I. HARD BASE IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 6.6F
• 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: 16270027
• MDR Text Key: 308820117
• Report Number: 3006260740-2023-00276
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025877
• UDI-Public: (01)00801741025877
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0604580
• Device Catalogue Number: 0604580
• Device Lot Number: REFX0171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• 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