MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PPRT MRI ISP 8GR INT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 9808560

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

One guidewire and one introducer needle were returned for evaluation.Functional, gross visual, microscopic visual and tactile evaluations were performed.The investigation is unconfirmed for the guidewire stuck in introducer needle, as the guidewire was able to be readily passed through the needle and no damage to the needle bevel was observed.However, the investigation is confirmed for damaged/unraveled guidewire, as the wrapping wire was observed to unraveled, elongated and bent.Furthermore, the core wire was observed to be broken.Just proximal to unraveled portion of the guidewire, there is a substantial amount of tissue/blood residue on small region of the guidewire.This is consistent with retracting the guidewire through needle (i.E.Removing the guidewire before removing the introducer needle).The definitive root cause could not be determined based upon available information.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that an 9808560 port & catheter allegedly experienced an incompatible component and frayed material.This information was received from one source.The incompatible component and frayed material involved one patient with no patient consequence.The age, weight, and sex were not reported for the patient involved.

• Brand Name: PPRT MRI ISP 8GR INT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• 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: 8803318
• MDR Text Key: 151461216
• Report Number: 3006260740-2019-02020
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027512
• UDI-Public: (01)00801741027512
• 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: 07/18/2019

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: 9808560
• Device Catalogue Number: 9808560
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 06/30/2019
• Initial Date FDA Received: 07/18/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1