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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA NEEDLE STRAIGHT CUTTING POINT KEITH ABDOMINAL .040X3.465, STERILE SURGICAL NEEDLE

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ASPEN SURGICAL PRODUCTS, CALEDONIA NEEDLE STRAIGHT CUTTING POINT KEITH ABDOMINAL .040X3.465, STERILE SURGICAL NEEDLE Back to Search Results
Model Number 213402
Device Problems Tear, Rip or Hole in Device Packaging (2385); Material Protrusion/Extrusion (2979)
Patient Problem Needle Stick/Puncture (2462)
Event Date 01/21/2022
Event Type  malfunction  
Manufacturer Narrative
No further information is available on the product at this time. The product was not returned for investigation. However if any additional relevant information is identified, the additional relevant information will be submitted in a supplemental report.
 
Event Description
Aspen surgical received a report from the end user indicating that a user was poked by needle protruding through the packaging. No intervention was required. The protruding needle is a sterility issue as the packaging was compromised. The issue was filed under our complaint handling system under number c-(b)(4).
 
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Brand NameNEEDLE STRAIGHT CUTTING POINT KEITH ABDOMINAL .040X3.465, STERILE
Type of DeviceSURGICAL 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 Key13549362
MDR Text Key290680690
Report Number1836161-2022-00005
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation
Type of Report Initial
Report Date 01/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number213402
Device Lot Number269958
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/21/2022
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

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