MAUDE Adverse Event Report: ETHICON INC. MONOCRYL (POLIGLECAPRONE 25) SUTURE; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number Y496H

Device Problem Detachment Of Device Component (1104)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).Conclusion: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported that on (b)(6) 2016 the surgeon performed an open bilateral inguinal hernia repair procedure on the patient with hcv positive and suture was used.During intradermic suturing, the needle detached from the suture wire above the needle holder after the passing through the sub-cutis.This caused an involuntary movement of the surgeon's right hand and in this way the surgeon stuck the thumb of his left hand.The finger was immediately pressed to stop a blood flow, disinfected with betadine and cleaned with sodium hypochlorite/naclo.The surgeon was transferred into the emergency room and blood examinations were scheduled.The surgeon opined that the contributing factor to the needle stick is, probably, a defective suture.Currently, the surgeon has no physical symptom.The first blood exam was negative and the surgeon is waiting for the next blood check.No further information has been provided.

Manufacturer Narrative

In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: MONOCRYL (POLIGLECAPRONE 25) SUTURE
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125, co; l salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5644262
• MDR Text Key: 44837632
• Report Number: 2210968-2016-08826
• Device Sequence Number: 1
• Product Code: GAN
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K964072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: Y496H
• Device Lot Number: KAM114
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/15/2016
• Initial Date FDA Received: 05/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/04/2016
• 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
• Patient Outcome(s): Required Intervention