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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X1.535 STERILE; SURGICAL NEEDLE
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ASPEN SURGICAL PRODUCTS, CALEDONIA NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X1.535 STERILE; SURGICAL NEEDLE Back to Search Results
Model Number 216703
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/02/2018
Event Type  Injury  
Manufacturer Narrative
Aspen surgical received an (b)(6) report ((b)(4)) from (b)(6) hospital in (b)(6) which indicated that a richard-"allen" 1/2 circle taper point mayo catgut needle broke inside the patient during use and had to be retrieved.The actual device was not available for evaluation.The manufacturing lot number was provided for review.During a procedure, the eye of the needle where the suture thread is passed through snapped off inside the patient's abdomen.The surgeon was able to retrieve the snapped end.The patient tolerated well and follow up care was not required.Analysis result of the finished good lot number was reviewed.No non-conformances were noted in the dhr relating to the reported issue.It is possible the root cause is related to a user error.The device's instructions for use indicate the needles should not be clamped directly on the eye of the needle or the point and should be applied to the flat portion of the needle about 1/4 of the needle length from the eye end.If a clamp was applied to the eye of the needle, it could have caused the eye to malfunction (break).Due to no sample or photo available, an evaluation of the device could not be performed.No further information is available of the product at this time.
 
Event Description
Aspen surgical received an (b)(6) report ((b)(4)) from (b)(6) hospital in (b)(6) which indicated that a richard-"allen" 1/2 circle taper point mayo catgut needle broke inside the patient during use and had to be retrieved.The report was filed in our complaint handling system as complaint #(b)(4).
 
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Brand Name
NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X1.535 STERILE
Type of Device
SURGICAL NEEDLE
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, CALEDONIA
6945 southbelt dr. s.e.
caledonia MI 49316
Manufacturer (Section G)
SAME AS ABOVE
Manufacturer Contact
jordan hackert
6945 southbelt dr. s.e.
caledonia, MI 49316
6165367508
MDR Report Key8024186
MDR Text Key125662871
Report Number1836161-2018-00111
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number216703
Device Lot Number119296
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/02/2018
Initial Date FDA Received10/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/13/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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