MAUDE Adverse Event Report: BARD REYNOSA S.A. DE C.V. POWERPORT MRI IMPLANTABLE PORT, SILICONE SINGLE-LUMEN, KIT, 9.6F; IMPLANTED PORT

Model Number 1809600

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided, therefore, a lot history review will be performed.The sample was not returned to the manufacturer for inspection/evaluation, and the company is still investigating the issue at this time.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 1809600 implanted port allegedly experienced catheter component missing.This information was received from one source.This malfunction does not involve patient.The (b)(6) year old male patient's weight was not provided.

Manufacturer Narrative

H10: the lot number for the device was not provided and a lot history review was not performed.The sample was not returned to the manufacturer for inspection/evaluation.The investigating is inconclusive for component missing.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.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.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 1809600 implanted port allegedly experienced catheter component missing.This information was received from one source.This malfunction does not involve patient.The 63 year old male patient's weight was not provided.

• Brand Name: POWERPORT MRI IMPLANTABLE PORT, SILICONE SINGLE-LUMEN, KIT, 9.6F
• Type of Device: IMPLANTED PORT
• Manufacturer (Section D): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• MDR Report Key: 10750248
• MDR Text Key: 213663989
• Report Number: 3006260740-2020-03546
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027130
• UDI-Public: (01)00801741027130
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

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
• Device Operator: No Information
• Device Model Number: 1809600
• Device Catalogue Number: 1809600
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 12/31/2020
• Supplement Dates FDA Received: 01/07/2021
• Patient Sequence Number: 1