MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOPLUS VIOLET 4/0(1,5)4X70CM HR22(MDDP; SUTURES

Model Number C0024707

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 03/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that the needle detach easily from the needle.It also was detached from the needle during opening of the package.

Manufacturer Narrative

Samples received: 1 open pouch.Analysis and results: there is (b)(4) previous complaint of this batch from the same end customer.Manufactured and distributed in the market (b)(4) units of this batch.There are no units in stock.We have received one open and unused sample.One of the four sutures inside the pouch has the needle detached from the thread.All sutures are still wound on the pack.We have tested the needle attachment of the other three sutures of the pack and the results fulfil requirements: the 1.42 kgf in average and 1.27 kgf in minimum (requirements: 0.46 kgf in average and 0.23 kgf in minimum).Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil b.Braun surgical requirements.Corrective/preventive actions: this complaint is recorded for trending analysis to assess if actions are needed in the future.

• Brand Name: MONOPLUS VIOLET 4/0(1,5)4X70CM HR22(MDDP
• 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: 6516234
• MDR Text Key: 73513565
• Report Number: 3003639970-2017-00204
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K031216
• 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,Followup
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• 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: C0024707
• Device Catalogue Number: C0024707
• Device Lot Number: 116304V004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/06/2017
• Device Age: 9 MO
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2016
• 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