MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. SYRINGE CAPS; SYRINGE, PISTON

Model Number 418012

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Event Description

As reported by the user facility: cytotoxic drug was prepared on (b)(6) 2022 and (b)(6) 2022 found leaking.Qc done after drug preparation; no leakage found.No injury reported.

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.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Although no sample was returned a picture showing a sample was provided for further evaluation.The returned picture was visually evaluated per specification and the reported defect of leakage was unable to be confirmed without a physical sample.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The actual defective device is a valuable tool in investigating the cause of this incident.Retained units were evaluated and passed the internal testing.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.Additionally, review of the batch history records was also performed for the reported lot number and no non-conformances or deviations were noted during the manufacturing process or final inspections.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: SYRINGE CAPS
• 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: 14850815
• MDR Text Key: 302700279
• Report Number: 2523676-2022-00332
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 04046964183331
• UDI-Public: (01)04046964183331
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K801311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 418012
• Device Catalogue Number: 418012
• Device Lot Number: 0061780507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• 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