FDA Adverse Event Malfunction Summary report: N

MONOCRYL PLUS SUTURE

MDR report key: 3843701 · Received June 2, 2014

Report

Report Number: 2210968-2014-06931
Event Type: Malfunction
Date Received: June 2, 2014
Date of Event: May 7, 2014
Report Date: May 19, 2014
Manufacturer: ETHICON INC.
Product Code: GAM
PMA / PMN Number: K050845
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TH
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCLUSION: AN OPENED ACTUAL SAMPLE COMPRISED A LABELED WINDING FORMER PLUS A DETACHED NEEDLE WAS RETURNED FOR EVALUATION. AS THE SUTURE MATERIAL WAS HANDLED, IT WAS FOUND TO HAVE DEGRADED. THIS HAD LED TO THE NEEDLE DETACHMENT. IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE SUTURE DEGRADATION AS THE FOIL PACKAGING MATERIAL HAD NOT BEEN RETURNED FOR EXAMINATION. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

Additional Manufacturer Narrative · 1

(B)(4). 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2014 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
321939	MONOCRYL PLUS SUTURE	SUTURE, ABSORBABLE, SYNTHETIC	GAM	ETHICON INC.	UNK	GC5DCBV

Patients

Seq	Age	Sex	Outcome	Treatment
1