MAUDE Adverse Event Report: B.BRAUN SURGICAL SA SUPRAMID BLACK 4/0 (1.5) 45CM HS15; SUTURES

Model Number G0712043

Device Problem Crack (1135)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: 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 and used sample with the thread broken.Without any closed samples a study cannot be performed to determine if the product fulfills the oem requirements.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill the oem requirements.Knot pull tensile strength results before releasing the product were 0.87 kgf in average and 0.82 kgf in minimum and fulfilled the requirements of the european pharmacopoeia.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: complaint is not justified.Without any closed samples a study can not be performed to see if the affected product does not fulfill the oem requirements.Note is taken of this incident and if any samples are received in the future, the case will be re-opened and analyzed.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 suture material was cracked.

• Brand Name: SUPRAMID BLACK 4/0 (1.5) 45CM HS15
• 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: 6531078
• MDR Text Key: 74155935
• Report Number: 3003639970-2017-00206
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2020
• Device Model Number: G0712043
• Device Catalogue Number: G0712043
• Device Lot Number: 615414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Distributor Facility Aware Date: 04/06/2017
• Date Manufacturer Received: 04/03/2017
• 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