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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEEDLE, SUTURING, DISPOSABLE
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NEEDLE, SUTURING, DISPOSABLE Back to Search Results
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/13/2021
Event Type  malfunction  
Event Description
When closing the subcutaneous layer at the end of the surgery, it was noted that one of the suture needles had broken, and part remained in the patient. The drapes and floor were searched but the needle was not found. All other counts were correct. The attending surgeon directed the resident to find and remove the needle fragment, if possible. Several x-rays were performed and read by radiology, and the needle was determined to be in the anterior abdominal wall. After a lot of searching and effort, the surgical team was unable to locate the needle, and they finished closing and sent the patient to pacu. The final count was documented as incorrect.
 
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Type of DeviceNEEDLE, SUTURING, DISPOSABLE
MDR Report Key14059369
MDR Text Key295130310
Report Number14059369
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/18/2022,07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/18/2022
Event Location Hospital
Date Report to Manufacturer04/08/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/08/2022 Patient Sequence Number: 1
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