MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. MONOMEND MAX 3/0 (2) 70CM HR26(M)VPL RCP; SYNTHETIC ABSORBABLE MONOFILAR SUTURE

Model Number 100523595

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Type  malfunction  

Manufacturer Narrative

Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.Under pma/510(k) number: k031216.If additional information becomes available a follow up report will be submitted.

Event Description

It was reported there was an issue with the monomend max suture.The client reported that the sutures were rejected from the last shipment due to the expiration date not being visible.No more information has been provided.

Manufacturer Narrative

D8: correction: yes.G2: correction: distributor/importer.Analysis and results: there are no previous complaints of this code batch.There are no units in stock in b.Braun surgical's warehouse.3,132 units of this code batch were manufactured and distributed in the market.We have received pictures showing that the expiry date in the boxes is not visible or it is partially visible.After an exhaustive investigation the root cause has been determined a displacement of the positioning of the labels versus the ribbon in the printing machine.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.Final conclusion: taking into account that the pictures received does not fulfil b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the failure in the pictures received.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, it has been decided that pegasus orders are separated from the rest of labeling orders to make sure that the labels are correctly placed in the printing machine in order to avoid this kind of defects.Actions on product distributed of this reference/batch: regarding the affected material, we will re-work it in our facilities and send the product correctly labeled to you.

• Brand Name: MONOMEND MAX 3/0 (2) 70CM HR26(M)VPL RCP
• 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: 15803281
• MDR Text Key: 306891522
• Report Number: 3003639970-2022-00476
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H10
• 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: Initial,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100523595
• Device Catalogue Number: 100523595
• Device Lot Number: 122232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2022
• 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