MAUDE Adverse Event Report: MERIT MEDICAL IRELAND LTD. DOUBLEPLAY HEMOSTASIS VALVE

Catalog Number MAP222

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 08/05/2015

Event Type  malfunction  

Manufacturer Narrative

One device has returned for evaluation.The evaluation is in process.A follow up report will be sent when the evaluation has been completed.

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.

Manufacturer Narrative

Device evaluation: one device was returned for evaluation.The device was visually inspected and a wrinkle was observed in the seal.A breach test was performed and no breach was found in the packaging.The complaint is unconfirmed.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: DOUBLEPLAY HEMOSTASIS VALVE
• Type of Device: HEMOSTASIS VALVE
• Manufacturer (Section D): MERIT MEDICAL IRELAND LTD.; parkmore industrial estate; galway, ; EI
• Manufacturer (Section G): MERIT MEDICAL IRELAND LTD.; parkmore industrial estate; galway, ; EI
• Manufacturer Contact: jerry mcphie ; 1600 west merit parkway; south jordan 84095 ; 8012084491
• MDR Report Key: 5032270
• MDR Text Key: 24129334
• Report Number: 9616662-2015-00010
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K925419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/05/2015

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: 07/31/2017
• Device Catalogue Number: MAP222
• Device Lot Number: K742804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2015
• 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