MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A.U. STEELEX ELEC 3/0 (2) 60CM HR17/GS65V; STEELEX ELECTRODE SET

Model Number C0992038

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

If additional information becomes available a follow up report will be submitted.

Event Description

It was reported an issue with steelex electrode suture.The client reported that the thread is damaged near the needle attachment area, the cover is incomplete.Additional information has been requested.

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market 1,044 units of this code-batch.There are no units in our stock.We have received a piece of thread with the needle attached.We have checked the open sample received and shows marks of needle holder or other surgical instruments near the attachment area with the thread, as can be seen in the enclosed picture.However, without any closed sample we cannot carry out an analysis in order to take a decision.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: when working with suture materials great care should be taken to ensure that the use of surgical instruments, such as tweezers and needle holders, does not cause the material to be damaged by being pinched or kinked.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.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.

• Brand Name: STEELEX ELEC 3/0 (2) 60CM HR17/GS65V
• Type of Device: STEELEX ELECTRODE SET
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.U.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL, S.A.U.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer Contact: martina laporte ; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 12828023
• MDR Text Key: 281999140
• Report Number: 3003639970-2021-00558
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K030556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0992038
• Device Catalogue Number: C0992038
• Device Lot Number: 120094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2021
• 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