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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS NEEDLE 1/2 CIRCLE CATCUT .050 X .984 STERILE; NEEDLE / SUTURING/ DISPOSABLE
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ASPEN SURGICAL PRODUCTS NEEDLE 1/2 CIRCLE CATCUT .050 X .984 STERILE; NEEDLE / SUTURING/ DISPOSABLE Back to Search Results
Model Number 216706
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/16/2023
Event Type  malfunction  
Manufacturer Narrative
Aspen surgical received a report from swiss medic indicating that a needle broke during a procedure.Incident occurred at the end user.The needle was used to fix the port to the cath and the needle broke off during the fixation of the port.The needle was successfully found using x-ray and removed from the patient without difficulty.The needle was disposed of and is not available for analysis.No injury was reported.Device history records were reviewed with no noted anomalies.No trends or anomalies were identified related to analysis of the finished good lot, raw material lot, or date of manufacturer.The contract manufacturer was notified and also confirmed there were no field trends evident.No sample or picture was provided.Our ability to perform additional investigation is limited.We will reopen if samples or additional details are received.Prior investigations of returned samples showed material deformation in certain areas suggesting causal factors associated with clapping too close the eye or not holding the needle holder in the correct area.This was indicative of user error.
 
Event Description
Aspen surgical received a report from swiss medic indicating that a needle broke during a procedure.Incident occurred at the end user.The needle was used to fix the port to the cath and the needle broke off during the fixation of the port.The needle was successfully found using x-ray and removed the patient without difficulty.The needle was disposed of and is not available for analysis.No injury was reported.
 
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Brand Name
NEEDLE 1/2 CIRCLE CATCUT .050 X .984 STERILE
Type of Device
NEEDLE / SUTURING/ DISPOSABLE
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS
6945 southbelt drive se
caledonia MI 49316
Manufacturer Contact
terry hall
6945 southbelt drive se
caledonia, MI 49316
6166987100
MDR Report Key18287191
MDR Text Key330039541
Report Number0001836161-2023-00041
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number216706
Device Lot Number329254
Was Device Available for Evaluation? No
Date Manufacturer Received11/08/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 SexMale
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