MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PPRT MRI ISP 8GR INT; IMPLANTABLE PORT

Model Number 9808560

Device Problems Fracture (1260); Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a lot history review could not be performed.The sample was returned to the manufacturer for inspection/evaluation.Investigation of the returned device was confirmed for fracture, and leak, but was unconfirmed for the reported dull introducer needle.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 9808560 implantable port allegedly had a dull introducer needle.This information was received from one source.The one reported malfunction involved one patient with no consequences.The age, sex, and weight of the patient was not provided.

• Brand Name: PPRT MRI ISP 8GR INT
• 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 ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10742649
• MDR Text Key: 213482108
• Report Number: 3006260740-2020-03504
• 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: 10/27/2020

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: 09/30/2020
• Initial Date FDA Received: 10/27/2020
• Type of Device Usage: N
• Patient Sequence Number: 1