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

Model Number C0933210

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/01/2017

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Incident: according to the feedback provided by our customer and the responsible sales rep, some sutures/threads detached from the needles.

Manufacturer Narrative

Samples received: 35 unopened pouches and 1 opened.Analysis and results: there are no previous complaints of this code batch.We manufactured (b)(4) units of this code batch.There are (b)(4) units in stock that have been requested for analysis.We have received from the customer 35 closed samples and one detached needle inside the second pack.We have tested the needle attachment of all closed samples received and the results are: 1.23 kgf in average and 0.32 kgf in minimum (ep requirements: 0.69 kgf in average and 0.35 kgf in minimum).One of the samples does not fulfil the minimum, but 1 low value in 15 tested units is accepted, according to the requirements of the european pharmacopoeia (ep).Additionally, we have conducted needle attachment test of 80 samples according to the standard iso 2859/1 and the results fulfil 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: DAFILON BLUE 3/0 (2) 45CM 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: 7133963
• MDR Text Key: 95902172
• Report Number: 3003639970-2017-00619
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2022
• Device Model Number: C0933210
• Device Catalogue Number: C0933210
• Device Lot Number: 617296V004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/04/2017
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other