FDA Adverse Event Malfunction Summary report: N

SAFIL UNDYED 4/0 (1,5) 45CM HSMP15 (M)

MDR report key: 3844787 · Received March 12, 2014

Report

Report Number: 2916714-2014-00120
Event Type: Malfunction
Date Received: March 12, 2014
Report Date: March 5, 2014
Manufacturer: B. BRAUN SURGICAL S.A.
Product Code: GAM
PMA / PMN Number: K031286
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MANUFACTURING SITE EVALUATION: THIS IS THE FIRST COMPLAINT OF THIS CODE BATCH. THIS IS THE FIRST COMPLAINT OF THIS CODE BATCH. THERE ARE NO UNITS IN OEM STOCK. WE HAVE RECEIVED ONE OPEN SAMPLE WITH ONLY THREAD INSIDE. THERE WAS NO NEEDLE ATTACHED TO THE THREAD, NOR INSIDE THE PACK. THE THREAD WAS STILL WOUND ON THE SUPPORT CARDBOARD. WE HAVE CHECKED THE THREAD END UNDER MICROSCOPE AND WE COULD SEE SIGNS OF DETACHMENT OF THE NEEDLE. LIKELY, THE NEEDLE DETACHED FROM THE THREAD WHILE OPENING THE PACK. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL OEM REQUIREMENTS. REMARKS: THE COMPLAINT IS JUSTIFIED FOR ISOLATED DETACHED NEEDLES, BUT THE CONCLUSION IS NOT CORRESPONDING ACCORDING TO THE IN PROCESS CONTROL RESULTS WHEN THIS BATCH WAS MANUFACTURED. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED).

Description of Event or Problem · 1

COUNTRY OF COMPLAINT: (B)(6). WHEN THE PACKAGE WAS OPENED NO NEEDLE WAS FOUND. HE LOOKED FOR IT AROUND THE OPERATION STAND FOR CONFIRMATION, BUT IT COULDN'T BE FOUND. THEREFORE, HE THOUGHT THAT NEEDLE HAD NOT BEEN PACKED IN A PACKAGE. SUTURE WAS FOUND IN A PACKAGE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
149208	SAFIL UNDYED 4/0 (1,5) 45CM HSMP15 (M)		GAM	B. BRAUN SURGICAL S.A.	C1049636	113175

Patients

Seq	Age	Sex	Outcome	Treatment
1