MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC PERFORMA PERIPHERAL CATHETER

Catalog Number 1624-C220M

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 05/10/2016

Event Type  malfunction  

Manufacturer Narrative

One device has returned for evaluation.A breach test was performed and a hole was found in the packaging.The complaint is confirmed.The root cause of the damage could not be confirmed.The device history record was reviewed and no exception documents were found.The complaint database was reviewed and no similar complaints for this lot number were found.

Event Description

The distributor reported a defect in the packaging.This was identified during their initial inspection of received product.The device was not sent to a user facility.

• Brand Name: PERFORMA PERIPHERAL CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC; 14646 kirby drive; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC; 14646 kirby drive; houston TX 77047
• Manufacturer Contact: jerry mcphie ; 1600 west merit parkway; south jordan, UT 84095 ; 8012084491
• MDR Report Key: 5729660
• MDR Text Key: 47537968
• Report Number: 3010665433-2016-00041
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K943739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2016

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: 03/31/2019
• Device Catalogue Number: 1624-C220M
• Device Lot Number: E930810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2016
• Initial Date Manufacturer Received: 05/23/2016
• Initial Date FDA Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1