MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X1.248 STERILE; SURGICAL NEEDLE

Model Number 216704

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

Aspen surgical received a report from the customer indicating that 1/2 circle taper needles are bending and breaking.Manufacturing lot number was available for review.A review of the device history record was completed.No non-conformance's were noted relating to the reported issue.No further information is available on the product at this time.Sample was not returned.However if sample becomes available and any additional relevant information is identified following completion of the evaluation, the additional relevant information will be submitted in a supplemental report.

Event Description

Aspen surgical received a report from the customer indicating that 1/2 circle taper needles are bending and breaking.The incident occurred at the user facility.No injury or death reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X1.248 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 Key: 9136387
• MDR Text Key: 167983351
• Report Number: 1836161-2019-00076
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 216704
• Device Lot Number: 150260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/03/2019
• 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 Number: 1