MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOSYN UNDYED 4/0 (1.5) 45CM DS19 (M); SUTURES

Model Number C0023204

Device Problems Product Quality Problem (1506); Out-Of-Box Failure (2311); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

Country of complaint: (b)(6).It was reported that a number of the sutures in the box are much finer than 4/0 and to them looked more like 6/0.

Manufacturer Narrative

Samples received: 18 unopened pouches.Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed in the market (b)(4) units.There are no units in stock in b.Braun surgical warehouse.We have received 18 closed pouches, when opened, 15 units were correct and 3 corresponded to a monosyn usp 6/0, 70cm long and ds00 needle and has been identified as reference (b)(4).Reviewed the batch manufacturing records of both products, monosyn usp 4/0 was packed (aluminum pouch) right before the monosyn 6/0 suture, by the same operator.In consequence, the most probable root cause if that no clean line was performed in the aluminum pouch packaging step.Some units of monosyn 6/0 were labelled as monosyn 4/0.The complaint is justified.Final conclusion: taking into account that the results of samples received do not fulfil the specifications of the european pharmacopoeia/b.Braun surgical specifications, we conclude that the complaint is justified.Corrective/preventive actions: complaint is added to (b)(4) project regarding mix-up inside first pack.

• Brand Name: MONOSYN UNDYED 4/0 (1.5) 45CM DS19 (M)
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 7267071
• MDR Text Key: 99929261
• Report Number: 3003639970-2018-00077
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• PMA/PMN Number: K011375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0023204
• Device Catalogue Number: C0023204
• Device Lot Number: 116093
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/08/2018
• Date Manufacturer Received: 01/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other