MAUDE Adverse Event Report: B.BRAUN SURGICAL SA DAFILON BLUE 4/0 (1.5) 45CM DS19; SUTURES

Model Number C0932205

Device Problem Fracture (1260)

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

Event Date 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

Samples received: 9 unopened and 1 open pouches.Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed (b)(4) units in the market.There are no units in stock in b.Braun surgical warehouse.We have received 9 closed samples and an open and unused unit.We have tested the knot pull tensile strength of the closed samples received and the results fulfill the requirements of the (b)(4) ((b)(4)): 1.10 kgf in average and 1.09 kgf in minimum ((b)(4) requirements: 0.51 kgf in average and 0.15 kgf in minimum).We have tested the needle attachment strength of the closed samples received and the results fulfill the requirements of the (b)(4) ((b)(4)): 0.68 kgf in average and 0.59 kgf in minimum ((b)(4) 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 fulfill (b)(4) and b.Braun surgical requirements.Final conclusion: although the results of the samples received fulfil the specifications of (b)(4)/ 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.

Event Description

Country of complaint: (b)(6).Suture breaking when tying.

• Brand Name: DAFILON BLUE 4/0 (1.5) 45CM DS19
• 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: 7307638
• MDR Text Key: 101574709
• Report Number: 3003639970-2018-00084
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K151165
• 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: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2022
• Device Model Number: C0932205
• Device Catalogue Number: C0932205
• Device Lot Number: 617064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Distributor Facility Aware Date: 02/05/2018
• Date Manufacturer Received: 02/05/2018
• 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