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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA YORK, PA INC. MALIK CYSTIC DUCT 8-1/2 M4 - ABDOMINAL

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INTEGRA YORK, PA INC. MALIK CYSTIC DUCT 8-1/2 M4 - ABDOMINAL Back to Search Results
Catalog Number 14-69
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Patient Involvement (2645)
Event Date 11/06/2018
Event Type  malfunction  
Manufacturer Narrative
The device was not yet returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
It was reported by a customer that on (b)(6) 2018, a 14-69 malik cystic duct had some residue or substance around the lockbox area. The product was not in contact with the patient. No patient injury or death alleged, and the event did not lead to increase the surgery time. No other clinical information received. Additional information had been requested.
 
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Brand NameMALIK CYSTIC DUCT 8-1/2
Type of DeviceM4 - ABDOMINAL
Manufacturer (Section D)
INTEGRA YORK, PA INC.
589 davies drive
589 davies drive
york PA 17402
Manufacturer (Section G)
INTEGRA YORK, PA INC.
589 davies drive
york PA 17402
Manufacturer Contact
kimberly shelly
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key8117051
MDR Text Key129459611
Report Number2523190-2018-00172
Device Sequence Number1
Product Code FFN
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number14-69
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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