MAUDE Adverse Event Report: B BRAUN SURGICAL SA DAFILON BLACK 10/0 (0.2) 30CM 2XDLM6

Model Number G1118706

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the batch records utilizing batch number 117482 revealed no similar incidences for this event.The device has not been returned for evaluation; therefore, no investigational results available.

Event Description

It was reported that after the package was opened, the needle and the suture were found to be separated.At the time of the event, the needle and suture were not in use on a patient.

Manufacturer Narrative

Samples received: 1 open pouch (and 1 unopened pouch from another batch that will not be analyzed).Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed (b)(4) units in the market.There are no units in stock in b.Braun surgical's warehouse.We have received an open sample (seems unused) with one of the needles detached from the thread.The other needle (double armed product) is connected to the thread.Nevertheless, needle attachment strength test to the attached needle cannot be done because the thread is broken approximately 1cm from the needle and the test cannot be carried out.Taking into account that no other customer complaints have been received concerning this issue for this code-batch we consider that this is an isolated unit.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.Final conclusion: in spite of receiving a defective sample, 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 analyse it.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 10/0 (0.2) 30CM 2XDLM6
• Type of Device: DAFILON
• 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, MO 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 7873474
• MDR Text Key: 120256326
• Report Number: 3003639970-2018-00559
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K990090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G1118706
• Device Catalogue Number: G1118706
• Device Lot Number: 117482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/22/2018
• Date Manufacturer Received: 09/26/2018
• 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: Unknown
• Patient Sequence Number: 1