MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. STEELEX MONOFIL 7 (9) 6X45CM LP; STAINLESS STEEL SUTURE

Model Number G0098531

Device Problem Unclear Information (4052)

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

Event Type  malfunction  

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code batch.72 units of this code batch were manufactured.48 units in stock in b.Braun surgical's warehouse.We have received from the customer pictures showing that one box containing ref.G0098531; 619445 was double labeled, one was correct and the other one correspond to ref.G0098523; 619445.Both products were manually labeled in the warehouse when preparing the shipments.The operator labeled correctly the products with one label but in the second one he/she crossed the labels of the two boxes.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.The complaint is confirmed but we consider that this is an isolated and accidental defect.Final conclusion: taking into account that the results of the pictures received do not fulfil the specifications of the european pharmacopoeia/b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the pictures received.We apologise for any inconvenience that this issue may have caused, and thank you for your collaboration.Actions on distributed product 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 an issue with steelex suture.The customer has found two labels in the product box; one corresponds to the product inside and the other to other reference of steelex.The product was not used on the patient.

• Brand Name: STEELEX MONOFIL 7 (9) 6X45CM LP
• Type of Device: STAINLESS STEEL SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer Contact: silvia orus ; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 10551980
• MDR Text Key: 215323389
• Report Number: 3003639970-2020-00328
• Device Sequence Number: 1
• Product Code: GAQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G0098531
• Device Catalogue Number: G0098531
• Device Lot Number: 619445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2020
• 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: N
• Patient Sequence Number: 1