MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. SAFSITE®; SET, ADMINISTRATION, INTRA

Model Number 415068

Device Problem Leak/Splash (1354)

Patient Problem Needle Stick/Puncture (2462)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number 400599925.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 1: when the iv is started and the safsite is put on the blood rushes out.The hospital facility staff has to get the blue end cap and stick it back on, then hook up to contrast and pray that it works.Several times they have had to re-stick the patient.

Manufacturer Narrative

Event 1: this report has been identified as b.Braun medical internal report number (b)(4).Multiple unused samples in blister packages were returned for evaluation.A weapage test was performed checking the valve at 1 psi for 5 seconds and no leaking was observed.A pressure test was also performed checking for leakage at 45 psi and no leakage was observed.Based on the results of the sample evaluation, the product met internal specifications.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: SAFSITE®
• Type of Device: SET, ADMINISTRATION, INTRA
• 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: 16933810
• MDR Text Key: 315237515
• Report Number: 2523676-2023-00172
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 04022495769862
• UDI-Public: (01)04022495769862
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942988
• 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: 05/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 415068
• Device Catalogue Number: 415068
• Device Lot Number: 0061871482
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2023
• 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