MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC PERICARDIOCENTESIS KIT

Catalog Number PC101

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

Patient Problem No Patient Involvement (2645)

Event Date 03/17/2016

Event Type  malfunction  

Manufacturer Narrative

One device has been returned for evaluation.The evaluation is still in progress.A follow up will be submitted when the evaluation has been completed.

Event Description

The distributor reported a scuff mark on the outer packaging of the kit.This was identified during incoming inspection and was not sent to a user facility.

Manufacturer Narrative

One device was returned for evaluation.The unit was examined visually and a scuff was found on the outer surface of the clear film.The customer's complaint is confirmed.Ingress testing was performed on the package and found that the sterility of the unit was compromised.The root cause is attributed to the manufacturing process.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.

• Brand Name: PERICARDIOCENTESIS KIT
• Type of Device: PERICARDIOCENTESIS KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC; 12701 kingston ave; chester VA 23836
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC; 12701 kingston ave; chester VA 23836
• Manufacturer Contact: jerry mcphie ; 1600 west merit parkway; south jordan, UT 84095 ; 8012084491
• MDR Report Key: 5780739
• MDR Text Key: 49129297
• Report Number: 1125782-2016-00011
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: PC101
• Device Lot Number: T901923
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2016
• 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