MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOSYN UNDYED 3/0 (2) 70CM GS60 (M); SUTURES

Model Number C0023285

Device Problems Out-Of-Box Failure (2311); Detachment of Device or Device Component (2907)

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

Event Date 10/13/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).The needle and thread (suture) are not connect.They were separated in the package.

Manufacturer Narrative

Samples received: 5 unopened pouches and 1 opened.Analysis and results: there are no previous complaints of the same code-batch.We manufactured and distributed in the market (b)(4) units of this code batch.There are no units in our stock.We have received five closed samples for analysis, and one open and unused sample with the needle detached from the thread (thread is still wound on the pack).Tightness test to the closed samples received has been performed and the units are tight.We have tested the needle attachment of the closed samples received and the results fulfil the requirements of the (b)(6): 1.85 kgf in average and 0.77 kgf in minimum (ep requirements: 0.69 kgf in average and 0.35 kgf in minimum).Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.Needle attachment results before releasing the product were 2.04 kgf in average and 1.22 kgf in minimum and fulfilled ep requirements.Final conclusion: although the results of the closed samples received fulfil the specifications of european pharmacopoeia/ b.Braun surgical specifications, we take note of this incidence 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.

• Brand Name: MONOSYN UNDYED 3/0 (2) 70CM GS60 (M)
• 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, barcelona 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 7006279
• MDR Text Key: 92212865
• Report Number: 3003639970-2017-00545
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 11/15/2017

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: 11/28/2021
• Device Model Number: C0023285
• Device Catalogue Number: C0023285
• Device Lot Number: 116411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/30/2017
• Date Manufacturer Received: 10/23/2017
• 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