MAUDE Adverse Event Report: ETHICON, INC. 3-0 VICRYL SUTURE CONTROL RELEASE; SUTURE, ABSORBABLE, SYNTHETIC

Lot Number MKZ295

Device Problem Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2019

Event Type  Injury  

Event Description

When provider was suturing the pt's incision and released needle from strand when the tip of the needle remained in the needle holder and the rest of the needle fell to the floor.Flat plate was taken to show nothing was remaining in the surgical incision.The two pieces of the broken needle were recovered and sent with an intact needle to be sent to further evaluate.Per clinical leader, possible user error.No harm to pt.

• Brand Name: 3-0 VICRYL SUTURE CONTROL RELEASE
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON, INC.
• MDR Report Key: 8470936
• MDR Text Key: 140686371
• Report Number: MW5085446
• Device Sequence Number: 1
• Product Code: GAN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: MKZ295
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR