MAUDE Adverse Event Report: B.BRAUN SURGICAL SA SUPRAMID BLACK 3/0 (2) 45CM DS19; SUTURES

Model Number G0712213

Device Problems Material Frayed (1262); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going device not returned.

Event Description

Country of complaint: (b)(6).The needle detached from the thread and the thread is frayed.

Manufacturer Narrative

Samples received: there are no samples available.Analysis and results: there are no previous complaints of this code batch.We manufactured (b)(4) units of this code batch.There are 11 units in our stock.We have received 8 closed samples from stock for analysis.We have tested the needle attachment of the samples received from stock and the results fulfil the requirements of the european pharmacopoeia (ep): 1.33 kgf in average and 0.94 kgf in minimum (ep requirements: 0.69 kgf in average and 0.35 kgf in minimum) on the other hand, we have checked the thread surface of the samples received from stock and is the correct and the usual one.Knotting test has also been conducted and the thread cover is correct, fraying does not appear after slipping the thread during this test.Final conclusion: although the results of the samples received from stock 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: SUPRAMID BLACK 3/0 (2) 45CM DS19
• 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: 7061910
• MDR Text Key: 93227047
• Report Number: 3003639970-2017-00559
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G0712213
• Device Catalogue Number: G0712213
• Device Lot Number: 616495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/10/2017
• Date Manufacturer Received: 10/31/2017
• 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