MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. MONOPLUS VIOLET 2/0(3)8X45CM HRB37STO(M); SYNTHETIC ABSORBABLE MONOFILAR SUTURE

Model Number M0024864

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 02/14/2022

Event Type  malfunction  

Event Description

It was reported an issue with monoplus suture.The client reported that a product of different size was mixed up in the box and found a wrong pouch but they do not know if it was in a box of this complaint or in a box of the related complaint.There is no patient involvement.All medwatch submissions related to this report are: 3003639970-2022-00083.No more information has been provided.

Manufacturer Narrative

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

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code-batch or units in our stock.We manufactured and distributed in the market 156 units of this code-batch.We have only received a picture showing an open sample of monoplus usp 1 8x45 cm, but the involved reference and batch is not known.According to the information received, this hospital uses m0024684 (this case) and m0024564 (b)(6).When the customer opens the package, found one monoplus of different size during surgery.However, the customer is not sure which box contains a unit of monoplus usp 1.We consider this case as confirmed due to the evidence of the picture received.However, without more information, a suitable investigation of the case cannot be performed, and the origin of this mix-up cannot be determined.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: taking into account that the picture received shows a unit that does not correspond to the code-batch of the product the customer received, we conclude that the complaint is confirmed by evidence of the picture 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.

• Brand Name: MONOPLUS VIOLET 2/0(3)8X45CM HRB37STO(M)
• Type of Device: SYNTHETIC ABSORBABLE MONOFILAR 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: martina laporte ; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 13768482
• MDR Text Key: 288112710
• Report Number: 3003639970-2022-00084
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0024864
• Device Catalogue Number: M0024864
• Device Lot Number: 121223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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