MAUDE Adverse Event Report: PROGRESSIVE MEDICAL PROGRESSIVE MEDICAL; VIAL2BAG DC 13MM

Model Number 3609 8135

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2015

Event Type  malfunction  

Event Description

We found a sealer vial2bag adapter with a potential hair.This particular adapter was not used and it was isolated.The mfr was notified on (b)(6) 2015 and the mfr initiated their eval process.We also pulled the adapters with the same lot number and expiration date.

• Brand Name: PROGRESSIVE MEDICAL
• Type of Device: VIAL2BAG DC 13MM
• Manufacturer (Section D): PROGRESSIVE MEDICAL; 997 horan drive; fenton MO 63026
• MDR Report Key: 5077716
• MDR Text Key: 25885325
• Report Number: MW5056155
• Device Sequence Number: 1
• Product Code: DTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/09/2015

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: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: 3609 8135
• Device Lot Number: 6872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1