MAUDE Adverse Event Report: CP MEDICAL BIOPSY SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number	931B-DEL
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received regarding lot 210302-51, size 4/0 nyl bla.According to the customer complaint, the suture was not attached to the needle.No injuries or delay in the surgical procedure was reported by the clinic.

• Brand Name: BIOPSY SUTURE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): CP MEDICAL; 1775 corporate dr; norcross, GA 30093 2960
• Manufacturer Contact: alfredo ferrer ; 1775 corporate dr; norcross,, GA 30093-2960
• MDR Report Key: 20149843
• Report Number: 3012164473-2024-00006
• Device Sequence Number: 17202672
• Product Code: GAR
• UDI-Device Identifier: 10790986006499
• UDI-Public: (01)10790986006499
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K001173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/16/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: 931B-DEL
• Device Lot Number: 210302-51
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown