MAUDE Adverse Event Report: B BRAUN SURGICAL SA DAFILON BLACK 9/0 (0.3) 15CM DRM5; SUTURES

Model Number G1111434

Device Problems Break (1069); Material Integrity Problem (2978); Material Twisted/Bent (2981)

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

Event Date 03/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional "needle break and bend easily during freeflab procedure causes bleeding.No major harm to patient.".

Manufacturer Narrative

Aesculap inc.(importer) is submitting this report on behalf of b.Braun surgical s.A.(manufacturer).Exemption number: e2014012 investigation: samples received: 1 open pot that contains 4 open samples.Analysis and results: there are three previous complaints, one of them regarding the same issue.We manufactured and distributed in the market 1,260 units of this code batch.There are no units in our stock.We have checked the four needles and we did not detect any breakage.Some needles are bent due to the manipulation with the clamper.However, without any closed sample a proper analysis cannot be performed.A review of the production record do not show any problem on needles.All steps are in accordance with internal specifications.Clamp tests doing during laboratory analysis are conform on all tested needles.Final conclusion: in spite of receiving these defective samples, without closed samples a suitable analysis cannot be performed.Nevertheless, we take note of this incidence and if any closed sample is received in the future, we will re-open the case and analyze it.No corrective/preventive actions needed.

• Brand Name: DAFILON BLACK 9/0 (0.3) 15CM DRM5
• Type of Device: SUTURES
• Manufacturer (Section D): B BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 8464009
• MDR Text Key: 140312136
• Report Number: 3003639970-2019-00311
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• PMA/PMN Number: K990090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/14/2019

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 Model Number: G1111434
• Device Catalogue Number: G1111434
• Device Lot Number: 118031
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/18/2019
• Initial Date Manufacturer Received: 03/08/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 04/18/2019
• Supplement Dates FDA Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1