MAUDE Adverse Event Report: B.BRAUN SURGICAL SA SAFIL VIOLET 0 (3.5) 70CM HR37S (M); SYNTHETIC ABSORBABLE BRAIDED S

Model Number C1048096

Device Problems Device Misassembled During Manufacturing /Shipping (2912); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.When additional information is received, a follow up report will be submitted.

Event Description

It was reported the needle size is smaller than it should be.The reporter indicated that the needle size does not match the size of the respective article.The size is less than it should be.This was noticed before use.No other information has been provided.Additional information has been requested, however, not yet received.

Manufacturer Narrative

(b)(6) (importer) is submitting this report on behalf of b.Braun surgical s.A.(manufacturer).Exemption number: e2014012.Investigation: samples received: 29 unopened pouches and 2 opened.Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market 5,292 units of this code-batch.There are no units in our stock.We have received 29 closed samples and 2 open and unused samples.We have checked all samples received and we have found that 18 of the closed samples received have the correct product inside (safil violet 0 (3.5) 70cm hr37s).However, the other 11 closed samples and the 2 open samples contain a different suture inside.The different suture has been characterized and has been identified as safil violet of usp 2/0 and 70 cm length with hr26 needle (equivalent code c1048042).Reviewed the batch manufacturing records, the most likely root-cause is due to the operation of line clearance was not performed correctly in the needle attachment process.Probably, some sutures of the previous order that corresponds to safil violet 2/0 70cm with hr26 needle were wound and packed as safil violet 0 70 hr37s.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.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.You will receive a credit note for one box as compensation.Corrective/preventive actions: complaint is added to six sigma project regarding mix-up inside first pack.

• Brand Name: SAFIL VIOLET 0 (3.5) 70CM HR37S (M)
• Type of Device: SYNTHETIC ABSORBABLE BRAIDED S
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 8552137
• MDR Text Key: 144998772
• Report Number: 3003639970-2019-00392
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• PMA/PMN Number: K031286
• 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: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2023
• Device Model Number: C1048096
• Device Catalogue Number: C1048096
• Device Lot Number: 118404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Distributor Facility Aware Date: 06/13/2019
• Date Manufacturer Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1