MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNKNOWN PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number UNK PORT

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the malfunction is unknown, therefore the manufacturing review could not be conducted.The device has not been returned for evaluation; therefore, the investigation is inconclusive for foreign material in the package as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause 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 unknown port allegedly experienced device contamination with chemical or other material.This information was received from one source.This event did not involve a patient as there was no patient contact.The patient's age, weight, and gender were not provided.

• Brand Name: UNKNOWN PORT
• 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: 9587248
• MDR Text Key: 190608159
• Report Number: 3006260740-2020-00069
• Device Sequence Number: 1
• Product Code: LJT
• 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: 01/14/2020

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: UNK PORT
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/14/2020
• Type of Device Usage: Initial
• Patient Sequence Number: 1