MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. TAMPER EVIDENT CAP; SYRINGE, PISTON

Model Number 418004

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 investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As reported by the user facility.Event 2: the transparent caps have white residue inside.No injury reported.

Manufacturer Narrative

Event 2: this report has been identified as b.Braun medical internal report number (b)(4).One (1) photo was product for evaluation.A visual evaluation was performed on the photo and no particulate or contamination was observed.The reported defect was not confirmed.A one-year historical review was performed against finished goods item number, and it was noted this is the only reported defect of this nature.Additionally, a 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 any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: TAMPER EVIDENT CAP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 16751424
• MDR Text Key: 313619953
• Report Number: 2523676-2023-00098
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 04046963579678
• UDI-Public: (01)04046963579678
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K801311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 418004
• Device Catalogue Number: 418004
• Device Lot Number: 0061855155
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2022
• 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