MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOSYN VIOLET 4/0 (1.5) 70CM HR22(M); SUTURES

Model Number C0022014

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 12/22/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).When customer opened this product, customer noticed that needle size is different.26mm size was mixed in 22mm size package.

Manufacturer Narrative

Samples received: 1 open unit.Analysis and results: initially the batch number of the involved product was not known because the customer is a regular user of the reference and the open unit did not have the part were the batch number is printed.The open sample received was typified and was a monosyn violet of usp 3/0 size, 70 cm long and hr26 needle.Corresponding to the code c0022025 that the end user never received.The analysis begun with the last batch supplied to the customer (117395) of which we also received one box from b.Braun aesculap (b)(4) warehouse (36 units) and other 36 units from b.Braun surgical warehouse.All 72 units were correct and corresponded to a monosyn violet 4/0 with hr22.Reviewed the batch manufacturing records the product did not overlap in any manufacturing step with any monosyn violet 3/0 with hr26 needle.So the batch was discarded in the analysis.The last but one batch supplied was 117255.Reviewed the batch manufacturing record of this batch, the same operator was present in the winding step of the involved product and the code c0022025 and batch 117255 that is a monosyn violet 3/0 70cm hr26 product.In consequence, the most probable root cause is that no clean line was performed in the winding step in the manufacturing process.The complaint is justified.(b)(4) units of the involved code batch were manufactured and distributed in the market.There are no previous complaints of the code batch nor units in b.Braun surgical warehouse.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.Actions on distributed product of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.When opening the unitary pack, sanitary staff should notice that the suture is different than expected and the suture would be discarded without being implanted on the patient.In case that the defective units were not detected, no harms are expected to the patient due to both references could be indicated in the same procedures.Corrective/preventive actions: complaint is added to six_05_2012 six sigma project regarding mix-up inside first pack.Training regarding clean line to the winding personnel of the monosyn cell.

• Brand Name: MONOSYN VIOLET 4/0 (1.5) 70CM HR22(M)
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 7207788
• MDR Text Key: 98056159
• Report Number: 3003639970-2018-00049
• 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: 02/13/2018

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 Model Number: C0022014
• Device Catalogue Number: C0022014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Distributor Facility Aware Date: 01/12/2018
• Initial Date Manufacturer Received: 12/27/2017
• Initial Date FDA Received: 01/19/2018
• Supplement Dates Manufacturer Received: 12/27/2017
• Supplement Dates FDA Received: 02/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other