MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOSYN VIOLET 4/0 (1.5) 70CM DS19 (M); SUTURES

Model Number C0022204

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).The needle didn't match with size of package.Wrong needle in suture.

Manufacturer Narrative

Samples received: 6 unopened and 4 open pouches.Analysis and results: there are no previous complaints of this code batch of which we manufactured and mainly distributed into the market 1,224 units.There are 72 units in b.Braun surgical warehouse that have been blocked.We have received 6 closed and 4 open pouches.All closed and two of the open samples have the correct product inside (monosyn violet 4/0 70cm ds19) but the other two open units have an incorrect needle attached.We have characterized the suture and corresponds to a monosyn violet usp 4/0, 70 cm long and hr17 needle.Reviewed production records, the product monosyn violet 4/0 with ds19 needle was packed (aluminum pack) just after the order that contained monosyn violet 4/0 with hr17 needle.The root cause is determined to be that clean line was not performed between the orders and some products of the second order were packed with the printing corresponding to the first order.Reviewed the batch manufacturing record, the product had an internal non conformity that was reworked and the product released fulfilled usp/ep and b.Braun surgical requirements.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 confirmed by evidence of the samples received.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions as an specific project is open regarding mix-up issues: six_05_2012.

• Brand Name: MONOSYN VIOLET 4/0 (1.5) 70CM DS19 (M)
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 7439862
• MDR Text Key: 105932125
• Report Number: 3003639970-2018-00216
• 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: 05/14/2018

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: 11/10/2021
• Device Model Number: C0022204
• Device Catalogue Number: C0022204
• Device Lot Number: 116454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/17/2018
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/18/2018
• Supplement Dates Manufacturer Received: 03/21/2018
• Supplement Dates FDA Received: 05/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other