MAUDE Adverse Event Report: B/ BRAUN SURGICAL SA SAFIL QUI+ UNDY 2/0 (3) 90CM HRT37(M); SYNTHETIC ABSORBABLE BRAIDED

Model Number C1046651

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the suture used in a procedure.During perineal repair of a postpartum patient, the safil "slipped" easily.The suture broke easily and the there was concern that this could cause delayed healing.It contributed to a delay of more than 15 minutes.

Manufacturer Narrative

Manufacturing site evaluation: samples received: none.Analysis and results: there are no previous complaints of this code-batch.There are no units in our stock.We have not received any sample for analysis.Without any closed sample we cannot carry out an analysis in order to take a decision.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.Remarks: when working with safil® quick suture material great care should be taken in order to ensure that the surgical instruments used, such as forceps or needle holders, do not cause any crushing or crimping damage to the suture material.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.

• Brand Name: SAFIL QUI+ UNDY 2/0 (3) 90CM HRT37(M)
• Type of Device: SYNTHETIC ABSORBABLE BRAIDED
• Manufacturer (Section D): B/ BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 8637469
• MDR Text Key: 146368587
• Report Number: 3003639970-2019-00428
• 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: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C1046651
• Device Catalogue Number: C1046651
• Device Lot Number: 118094
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/22/2019
• Date Manufacturer Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1