MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. MANIPLER AZ - 35W SKINSTAPLER; SKIN STAPLER, TEXTILE SKIN CLOSURE

Model Number 783100

Device Problem Unsealed Device Packaging (1444)

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

Event Description

It was reported that there was an issue with manipler skin stapler.The client reported that the film of the package is peeling off, is not properly sealed.This issue has happened several times and is observed when the product box is opened.Additional data has been requested.

Manufacturer Narrative

Samples received: 1 open and unused unit.Analysis and results: there are no previous complaints of this code-batch or units in b.Braun surgical's warehouse.We distributed in the market 8,796 units of this code-batch.1) production record sheet check: - no abnormalities were found in the record sheet.2) returned product check: - the corner of the barcode label was peeled off due to the rumpling of the tyvek.- the color of the tyvek was changed only in the area where there was no transfer of the coating agent, and it was rumpled and wavy.It seems that it was wet once and dried out.- the area on blister pack with no transfer of the coating agent can be seen a heat exposure mark of having been sealed by heat.- melted coating agent by heat was confirmed on the blister pack.- melted coating agent by heat was confirmed on the tyvek.- the one area of the tyvek was more transparent color than the other area, and it seems like some kind of liquid had dropped on it, though it is difficult to conclude.As the result of the investigation of the returned stapler, the blister pack and tyvek in the areas where there was no transfer of seal mark showed heat exposure mark, confirming that sealing had been performed.On the area of tyvek where there was no transfer of the seal mark, there was the mark that looked like it had dried up after being exposed to some kind of liquid.We confirmed that peeling off the tyvek after being in contact with ethanol for a certain period of time produced the same result as the pictures received, which is similar to the condition of the returned stapler.Based on the above, it is assumed that the unsealed package occurred due to the dissolution of the coating agent when the tyvek was exposed to ethanol or other liquids for a certain period of time.Final conclusion: the case is considered not confirmed by evidence of the sample received.Nevertheless, we take note of this incidence in order to assess if new or additional actions are needed.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: MANIPLER AZ - 35W SKINSTAPLER
• Type of Device: SKIN STAPLER, TEXTILE SKIN CLOSURE
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 10917260
• MDR Text Key: 223445371
• Report Number: 3003639970-2020-00450
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): Y
• PMA/PMN Number: SEE H10
• 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: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 783100
• Device Catalogue Number: 783100
• Device Lot Number: U208008600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1