MAUDE Adverse Event Report: COVIDIEN LP SYNETURE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	VLOCN0346
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Patient undergoing surgical procedure and required absorbable suture.When the or staff pulled the suture asked for by the provider, she pull the non-absorbable version of the same brand.The provider used the incorrect suture on the patient requiring a return to surgery to remove it and replace it with the absorbable suture.The packaging on the non-absorbable suture has a green colored strip at the top but the words below describe it as blue.The absorbable suture has no colored strip but states green on the front of the package.Both sutures are stored next to one another and labeled on the shelf correctly.Appears human error occurred with this 'look alike, sound alike" product.

• Brand Name: SYNETURE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 15713767
• Report Number: 15713767
• Device Sequence Number: 5126761
• Product Code: GAT
• UDI-Device Identifier: 10884521762527
• UDI-Public: (01)10884521762527
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/28/2022
• Report Date (Section F): 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: VLOCN0346
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Race: White
• Date Report Sent to FDA: 10/28/2022