MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. SAFEDAY; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	352904
Medical Device Problem Codes	Free or Unrestricted Flow (2945); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as event 1 of 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 or Problem Description
Event 1: as reported by the user facility: "we have noticed that the filtered tubing we have been using is leaking at the end port between two of the plastic pieces.This is happening even when the roller clamp and the slide clamp are closed.Even when both clamps are closed, the tubing still leaks, and if the end of the tubing is raised above the bag, air flows into the end of the tubing.".
Additional Manufacturer Narrative
Event 1: this report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample was provided for evaluation.Visual examination of the sample was unable to note any defects.Sample was subjected to leak testing, during which the roller clamp was activated in order to cut off flow with passing results, no leakage was noted on the set.Based on the evaluation of the samples the reported defect is not confirmed.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: SAFEDAY
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown 18109
• MDR Report Key: 11021285
• Report Number: 2523676-2020-00351
• Device Sequence Number: 16361160
• Product Code: FPA
• UDI-Device Identifier: 04046964181993
• UDI-Public: 04046964181993
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K955585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 352904
• Device Catalogue Number: 352904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1