MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT SLIM, 6FR, MI KIT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1716070J

Device Problems Component Incompatible (1108); Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was returned to the manufacturer for evaluation.Therefore, the investigation is confirmed for the alleged improper fit of the guidewire into the needle due to the loose guidewire braiding.The definitive root cause could not be determined based upon available information.The device is labeled for singe use.The catalog number identified has not been cleared in the us, but is similar to the powerport slim, 6fr, mi kit product that are cleared in the us.The pro code for the powerport slim, 6fr, mi kit product is identified.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 1716070j port & catheter, implanted,subcutaneous, intravascular allegedly experienced improper fit of the guidewire into the needle.This information was received from one source.One patient was involved with no reported patient injury.Age, gender and weight of the patient was not provided.

• Brand Name: POWERPORT SLIM, 6FR, MI KIT
• 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 ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10286672
• MDR Text Key: 199268569
• Report Number: 3006260740-2020-02498
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741163739
• UDI-Public: (01)00801741163739
• 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: 07/16/2020

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 Catalogue Number: 1716070J
• Device Lot Number: REDT4456
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/16/2020
• Type of Device Usage: N
• Patient Sequence Number: 1