MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOSYN VIOLET 3/0 (2) 70CM HR26 (M); SUTURE

Model Number C0022025

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device not available for evaluation.

Event Description

Country of complaint: (b)(6).Ot nurse opened (b)(4) to use but inside the box of there is 1 pc of (b)(4) which she was not aware of.After opening and taking out the suture for use, she realized that it was actually the wrong needle.

Manufacturer Narrative

Samples received: no samples received but pictures showing the defect and product labeling.Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed (b)(4) units in the market.There are no units in stock in b.Braun surgical warehouse.We have received a picture showing one pouch labeled as monosyn violet 3/0 70cm dsmp19 needle, batch 117044.According to the end customer, the remaining 35 pouches were correct and correspond to monosyn violet 3/0 70cm hr26 ((b)(4)).Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.The mix-up was produced in packaging area.Both products were packed one after the other.We assume that clean line in the manufacturing process was not performed correctly.Final conclusion: taking into account that the results of sample received does not fulfil b.Braun surgical specifications, we conclude that the complaint is justified.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.Automatic packaging implemented and will prevent this kind of issues.

• Brand Name: MONOSYN VIOLET 3/0 (2) 70CM HR26 (M)
• Type of Device: SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• MDR Report Key: 7422725
• MDR Text Key: 105445058
• Report Number: 3003639970-2018-00182
• 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: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2022
• Device Model Number: C0022025
• Device Catalogue Number: C0022025
• Device Lot Number: 117044
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/23/2018
• Initial Date Manufacturer Received: 03/15/2018
• Initial Date FDA Received: 04/11/2018
• Supplement Dates Manufacturer Received: 03/15/2018
• Supplement Dates FDA Received: 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other