MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOSYN UNDYED 5/0 (1) 70CM DS19 (M); SUTURES

Model Number C0023403

Device Problems Failure To Adhere Or Bond (1031); Device Misassembled During Manufacturing /Shipping (2912)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 1 unopened pouch.Analysis and results: there are previous complaints of this code batch regarding needle detachment.The (b)(4) units were manufactured and distributed of this code batch, there are no units in stock.Tightness test to the closed sample received has been performed and the units are tight.Tested the needle attachment of the closed samples received and the results do not fulfill the oem requirements.Tested the knot pull tensile strength of the closed sample received and the results fulfills the oem requirements.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfills the oem requirements.As instructed for use: "when working with monosyn® suture materials great care should be taken to ensure that the use of surgical instruments, such as tweezers and needle holders, does not cause the material to be damaged by being pinched or kinked".Final conclusion: taking into account that the results of needle attachment of the closed samples received do not fulfill the oem specifications, it is concluded that the complaint is justified.Corrective/preventive actions: according to the internal procedures, there is no need to establish corrective or 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).It was reported that the thread was detached from the needle when the suture package was opened.

• Brand Name: MONOSYN UNDYED 5/0 (1) 70CM DS19 (M)
• 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: 6370038
• MDR Text Key: 68773557
• Report Number: 3003639970-2017-00076
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K011375
• 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: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2019
• Device Model Number: C0023403
• Device Catalogue Number: C0023403
• Device Lot Number: 114375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Distributor Facility Aware Date: 02/06/2017
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 03/01/2017
• 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