MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. MONOPLUS VIOLET 4/0 (1,5) 70CM HR22B (M); SYNTHETIC ABSORBABLE MONOFILAR SUTURE

Model Number C0024522

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Patient Involvement (2645)

Event Date 03/11/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was an issue with monoplus packaging.The client reported that the outer sterile foil is missing (secondary package).This is the second time that occurs.The event occurred prior to use, there is no patient involvement.

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market (b)(4) of this code-batch.There are no units in stock in b.Braun surgical's warehouse.We have received one pouch without the second pack.According to the information received, the customer found this unit inside the box without the secondary package.The likely root-cause of the defect is an operator mistake during conditioning process.This non-conforming unit was probably placed inside the box due to an operational error and the operator did not notice that.Taking into account that no other customer complaints have been concerning this issue for this code-batch, we consider that this is an isolated and accidental unit, but whole batch is correct.Final conclusion: taking into account that the sample received does not fulfil b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the failure in 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.You will receive a credit note for one box of product as compensation.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 4/0 (1,5) 70CM HR22B (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
• MDR Report Key: 10325068
• MDR Text Key: 200458897
• Report Number: 3003639970-2020-00274
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• PMA/PMN Number: K031216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0024522
• Device Catalogue Number: C0024522
• Device Lot Number: 119413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1