MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MRI POWER PORT; IMPLANTABLE PORT

Model Number 1808002

Device Problems Component Incompatible (1108); Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot met all release criteria.Device history records were reviewed and no deviations/issues were identified or associated with this problem in regards to product materials or during manufacturing, packaging or qc inspection process.All necessary inspections were performed throughout all manufacturing, packaging and inspection activities and for raw material utilized in the manufacture of this lot in regards to the described problem.One introducer needle and one guidewire were returned for evaluation.Gross visual and microscopic visual evaluations were performed.The investigation is inconclusive for improper guidewire/needle, as the guidewire and needle were received separated from each other and the conditions at the time of the reported event could not be reproduced in the lab.However, the investigation is confirmed for elongated/unraveled guidewire, as unraveling was observed near the distal end of the guidewire.Residue was observed throughout the needle and the guidewire.The definitive root cause could not be determined based upon available information.Blood/tissue residue in the needle and/or on the guidewire, and/or retracting the guidewire through the needle may have contributed to the observed guidewire unraveling.Alternatively, the guidewire unraveling may have contributed to the reported event.However, the origin and time of the observed unraveling is unknown.It is unknown if procedural issues contributed to the reported event.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 1808002 implantable port allegedly during insertion, the introduction needle got stuck on the guidewire.There was no reported patient injury.This information was received from one source.Patient age, weight, and gender were not provided.

• Brand Name: MRI POWER PORT
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8818890
• MDR Text Key: 152031627
• Report Number: 3006260740-2019-02137
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026997
• UDI-Public: (01)00801741026997
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2019

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: 1808002
• Device Catalogue Number: 1808002
• Device Lot Number: RECX3207
• Initial Date Manufacturer Received: 06/30/2019
• Initial Date FDA Received: 07/23/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1