MAUDE Adverse Event Report: B.BRAUN SURGICAL SA DAFILON BLUE 2/0 (3) 75CM DS24; SUTURES

Model Number C0935360

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 1 unopened pouch.Analysis and results: there are no previous complaints of this code-batch.Manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in stock.Thread surface on the closed sample received is the current and the usual one, no defects have been found.On the other hand, sewing test on artificial skin tissue has been conducted with the sample received and the thread slips correctly through the tissue.Moreover, the stitches have been removed from the tissue without difficulty.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill the oem requirements.Final conclusion: although the results of the samples received fulfill the oem specifications, note of this incident is taken 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).It was reported that after sutures, thyroid - the day after a surgery; hernia - 7th day after a surgery.In one case, the suture was removed - it was very painful for a patient.All med watch submissions related to this report are: 3003639970-2018-00173, 3003639970-2018-00204, 3003639970-2018-00205.

• Brand Name: DAFILON BLUE 2/0 (3) 75CM DS24
• 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, 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7430988
• MDR Text Key: 105931186
• Report Number: 3003639970-2018-00204
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K990090
• 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: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2022
• Device Model Number: C0935360
• Device Catalogue Number: C0935360
• Device Lot Number: 617151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Distributor Facility Aware Date: 04/05/2018
• Date Manufacturer Received: 02/27/2018
• 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
• Patient Outcome(s): Other