MAUDE Adverse Event Report: B.BRAUN SURGICAL SA DAFILON BLUE 5/0 (1) 45CM DGMP13 DDP; SUTURES

Model Number G0933906

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 04/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 1 open pouch.Analysis and results: there are no previous complaints of the same code-batch.Manufactured and distributed (b)(4) units of this code batch.There are no units in stock.Received one open and unused sample with the needle detached from the thread, and the thread is still wound on the pack.Without any closed samples an analysis cannot be performed to determine if the product fulfills the oem requirements.Final conclusion: complaint is not justified.Without any closed samples a study can not be performed to see if the affected product does not fulfill the oem requirements.Note is taken of this incident and if any samples are received in the future, the case will be re-opened and analyzed.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).It was reported that the needle detached from the thread.

• Brand Name: DAFILON BLUE 5/0 (1) 45CM DGMP13 DDP
• 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: 6540477
• MDR Text Key: 74316253
• Report Number: 3003639970-2017-00233
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2019
• Device Model Number: G0933906
• Device Catalogue Number: G0933906
• Device Lot Number: 614473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Distributor Facility Aware Date: 04/21/2017
• Initial Date Manufacturer Received: 04/13/2017
• Initial Date FDA Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other