MAUDE Adverse Event Report: B.BRAUN SURGICAL SA SAFIL C VIOLET 1 (4) 15M; SUTURES

Model Number F1038106

Device Problems Product Quality Problem (1506); Out-Of-Box Failure (2311); Material Twisted/Bent (2981)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 1 open cassette.Analysis and results: there are no previous complaints of this code batch.Manufactured and distributed in the market (b)(4) units of this code batch.There are no units in stock.Received one open cassette.Thread seems damaged inside the cassette near the rubber valve (approximately 2 cm of thread).This defect could be due to a different tension between the core of the thread (internal structure) and the group of fibers of braiding (external structure) during the winding of the thread in manufacturing process.Pulled out the thread from the cassette and after removing 1 meter approximately the defect has disappeared and the structure of the braiding thread has returned to its usual appearance.Taking into account that there are no previous complaints for safil cassette product concerning this issue, we consider that this is an isolated and accidental case.Final conclusion: this complaint is justified.Corrective/preventive actions: this complaint is recorded for trending analysis to assess if actions are needed in the future.

Event Description

Country of complaint: (b)(6).The thread fibers separate from one another.Inside the box, the thread twists.

• Brand Name: SAFIL C VIOLET 1 (4) 15M
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7006281
• MDR Text Key: 92212953
• Report Number: 3003639970-2017-00555
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2020
• Device Model Number: F1038106
• Device Catalogue Number: F1038106
• Device Lot Number: 117273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Distributor Facility Aware Date: 11/06/2017
• Date Manufacturer Received: 10/16/2017
• 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