MAUDE Adverse Event Report: B. BRAUN SURGICAL SA OPTILENE 5/0 (1) 90CM 2XHR22 CV RCP; SUTURES

Model Number G3090975

Device Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

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

Event Date 08/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: pending further information.

Event Description

It was reported by the healthcare professional to the company sales representative "two sutures detached from needle upon taking out of packet.The two needles bent horribly.".

Manufacturer Narrative

Investigation received 9/27/2018.Samples received: 2 open and used samples.Analysis and results: there are no previous complaints of the same code-batch.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in our stock.We have received two open and used samples which contains 2 needles each one (reference with double needle) to analyze this complaint.One of the needles is detached from the thread.However, without any closed sample we cannot carry out an analysis in order to take a decision.Needle attachment strength results before releasing the product were 0.40 kgf in average and 0.27 kgf in minimum and fulfilled the requirements of the european pharmacopoeia (ep requirements: 0.23 kgf in average and 0.11 kgf in minimum).On the other hand, we have checked the needles received and two of them are bent and damaged.There are several marks of the needle holder on needle tip area and needle body (see enclosed picture).The other two needles have been tested for bending strength and the results fulfils the specifications: 3.17 nxcm and 3.20 nxcm in minimum (minimum bending strength specification for this needle: >3.1nxcm).Bending strength result before releasing the product was 3.16 nxcm and fulfilled the specification (minimum bending strength specification for this needle: >3.1nxcm).Remarks: care should be taken to avoid damaging the needle when using the suture material.Always grasp the needle in a section 1/3 to 1/2 of the distance from the fiber attachment end to the needle point, never at the end where the fiber is attached or the needle point.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.Final conclusion: although the results of tested needles fulfil the specifications, we take note of this incidence in order to assess if new or additional actions are needed.In regards to the needle detachment defect, 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.Corrected data: added additional detail of device use: during mdr review it was determined that the initial mdr did not include detail of device use.

Event Description

The suture was used for hepatic surgery, specifically, the hepatic vein.The hospital is unable to give patient details.

• Brand Name: OPTILENE 5/0 (1) 90CM 2XHR22 CV RCP
• Type of Device: SUTURES
• Manufacturer (Section D): B. BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 7877675
• MDR Text Key: 120388790
• Report Number: 3003639970-2018-00572
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• PMA/PMN Number: K133890
• 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: 10/12/2018

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: 02/19/2021
• Device Model Number: G3090975
• Device Catalogue Number: G3090975
• Device Lot Number: 117442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Distributor Facility Aware Date: 08/21/2018
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/14/2018
• Supplement Dates Manufacturer Received: 09/06/2018
• Supplement Dates FDA Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1