MAUDE Adverse Event Report:; ADMINISTRATION SET

Catalog Number 7F5100

Device Problem Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The device involved has not been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As reported by the customer: a spike was found with black particulate on the tip.No injuries were reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample was returned for evaluation.Two (2) pictures were also provided.The returned sample and pictures were visually evaluated per specification.The tips of the piercing device were observed to be black.The returned pictures depicts the same defect.Incidents of this nature are attributed to clogged/blocked vents in the mold.All molds have very small vents cut into the steel so that the gases from the plastic can escape when the plastic enters the cavities.The material used in the spike is abs and it is a very dirty material which means it lets off gases more than most materials.These off gases can also clogged vents.The mold was then validated to prevent this issue happening in future.Retained units were evaluated and passed the internal testing.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.

• Type of Device: ADMINISTRATION SET
• MDR Report Key: 12452666
• MDR Text Key: 270791542
• Report Number: 2523676-2021-00300
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7F5100
• Device Lot Number: 0061723127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Date Manufacturer Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1