MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. SAFIL VIOLET 1 (4) 90CM HR48 (M); SUTURE

Model Number C1048562

Device Problems Break (1069); Device Issue (2379); Material Integrity Problem (2978); Physical Property Issue (3008)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation on-going.Device not returned.

Event Description

Sutures used in caesarean section, uterine suture, and broke during the surgery.(b)(6).

Manufacturer Narrative

Samples received: none.Analysis and results: there are no previous complaints of this code batch of which (b)(4) units were manufactured and distributed in the market.There are no units in stock in b.Braun surgical warehouse.As no samples have been received and no units are available in b.Braun surgical, s.A.We have only reviewed the batch manufacturing record and this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.Final conclusion: without samples we are not in position of studying if the affected product does not fulfil the specifications.In consequence, a proper analysis cannot be done.Nevertheless, we take note of this incidence and if any sample is received in the future, we will re-open the case and analyze it.Please note that when no samples are received our analysis is very limited.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.

• Brand Name: SAFIL VIOLET 1 (4) 90CM HR48 (M)
• Type of Device: SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL S.A.; 121 carretera de terrassa; rubi, barcelone 08191 ; SP 08191
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 7284104
• MDR Text Key: 100671042
• Report Number: 3003639970-2018-00100
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K031286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C1048562
• Device Catalogue Number: C1048562
• Device Lot Number: 116396
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/08/2018
• Date Manufacturer Received: 01/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other