MAUDE Adverse Event Report: B.BRAUN SURGICAL SA SUPRAMID BLACK 5/0 (1) 45CM DS16; SUTURES

Model Number G0712124

Device Problems Break (1069); Crack (1135)

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

Event Type  malfunction  

Manufacturer Narrative

Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or any other technological characteristics with a medical device that is registered within the u.S.(b)(4).Manufacturing site evaluation: samples received: 9 unopened pouches.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.Tested the knot pull tensile strength of the samples received and the results fulfill the oem requirements.Remarks: when working with suture materials great care must be taken to ensure that the use of surgical instruments, such as tweezers and needle holder, does not lead to damage by pinching and kinking.Final conclusion: although the results of the samples received fulfill the oem specifications, note of this incident is taken in order to assess if new or additional actions are needed.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.

Event Description

Country of complaint: (b)(6).It was reported that the threads in the package was cracked and breaking.

• Brand Name: SUPRAMID BLACK 5/0 (1) 45CM DS16
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 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: 6376008
• MDR Text Key: 69019800
• Report Number: 3003639970-2017-00083
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: G0712124
• Device Catalogue Number: G0712124
• Device Lot Number: 616305V003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Distributor Facility Aware Date: 02/10/2017
• Date Manufacturer Received: 02/01/2017
• 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