MAUDE Adverse Event Report: B.BRAUN SURGICAL SA DAFILON BLACK 8/0 (0.4) 15CM DRM6; SUTURES

Model Number G1118170

Device Problem Bent (1059)

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

Event Date 08/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).The needle bent during surgery.The surgeon completed the surgery with no problems with another type of suture.

Manufacturer Narrative

Samples received: 8 unopened units.Analysis and results: there are no previous complaints of this code batch.Manufactured and distributed (b)(4) units of this code batch, there are no units in stock.The needles of the closed samples received are the current and usual ones.The bending strength for these micro-needles was not able to be tested.The bending strength depends basically also from the form of the profile.Since this needle types are on the market the profile has not changed so the hardening process has correlation with the bending strength.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfilled the oem requirements.Remarks: to avoid damaging needle points and swage (attachment) area, the needle should be grasped in an area from 1/3 to 1/2 of the distance from the swaged end of the point.Final conclusion: complaint is not justified.Although the results of the samples received fulfills the oem specifications, note is taken of this incident 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 BLACK 8/0 (0.4) 15CM DRM6
• 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: 5925030
• MDR Text Key: 53835335
• Report Number: 2916714-2016-00717
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2021
• Device Model Number: G1118170
• Device Catalogue Number: G1118170
• Device Lot Number: 116174V004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/10/2016
• Device Age: 4 MO
• Date Manufacturer Received: 09/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2016
• 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