MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. OPTILENE 2/0 (3) 75CM HR30 (M) RCP; OPTILENE NON-CARDIOVASCULAR

Model Number C3090047

Device Problem Material Twisted/Bent (2981)

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

Event Type  malfunction  

Manufacturer Narrative

Analysis and results: there are no previous complaints of this 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 one open and used sample from the customer for analysis.The needle of the sample received is bent and shows marks of needle holder or other surgical instrument near attachment area as can be seen in enclosed picture.The bent area of the needle is close to these marks.Therefore, the most probably is that the needle has been damaged and bent due to wrong handling.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.Remarks: care should be taken to avoid damage when handling surgical needles.Grasp the needle in an area one-third (1/3) to onehalf (1/2) of the distance from the attachment end to the point.Grasping in the point area could impair the penetration performance and cause fracture of the needle.Grasping at the butt or attachment end could cause bending or breakage.Final conclusion: the needle received showed a damage in the attachment area caused by a wrong handling.However, we take note of this incidence in order to assess if new or additional actions are needed.The case is considered not confirmed by evidence of the sample received.Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.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

It was reported that there was an issue with optilene suture.The client reported that the needle bent during cesarean case closure.Additional information has not been provided.

• Brand Name: OPTILENE 2/0 (3) 75CM HR30 (M) RCP
• Type of Device: OPTILENE NON-CARDIOVASCULAR
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; carretera de terrassa, 121; rubí, 08191 ; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL, S.A.; carretera de terrassa, 121; rubí, 08191 ; SP 08191
• Manufacturer Contact: silvia orús ; carretera de terrassa, 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 10018290
• MDR Text Key: 189642098
• Report Number: 3003639970-2020-00202
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K133890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/30/2020

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: 12/15/2022
• Device Model Number: C3090047
• Device Catalogue Number: C3090047
• Device Lot Number: 117505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 05/01/2020
• 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