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U.S. Department of Health and Human Services

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

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MERIT MEDICAL IRELAND LTD. DOUBLEPLAY HEMOSTASIS VALVE Back to Search Results
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.
 
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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 Key5032270
MDR Text Key24129334
Report Number9616662-2015-00010
Device Sequence Number1
Product Code DTL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K925419
Number of Events Reported1
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 Date07/31/2017
Device Catalogue NumberMAP222
Device Lot NumberK742804
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/26/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/16/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/09/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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