MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. SAFEDAY¿; SET, ADMINISTRATION, INTRA

Catalog Number	352894
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 report will be submitted when the results of the investigation become available.
Event or Problem Description
As reported by the user facility: as the nurse was administrating the adriamycin iv push, the ll adapter stripped off the y-site of the safeday set, causing the adriamycin to leak.A chemo kit was used to clean up the spill.No injuries were reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample without packaging was returned for evaluation.The set was spiked into a baxter 100ml pab of sodium chloride and a loose teva adapter was also returned.The returned iv set was leakage tested, per specification, with passing results.Both safeday injection sites were accessed with a syringe and the set was tested a second time with passing results.Therefore, the reported defect was not able to be replicated or confirmed.Review of the discrepancy management system (dsms) database performed for the reported lot number revealed no abnormalities or non-conformances noted during in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.

• Brand Name: SAFEDAY¿
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• MDR Report Key: 7774086
• Report Number: 9614279-2018-00130
• Device Sequence Number: 11110689
• Product Code: FPA
• UDI-Device Identifier: 04046964181894
• UDI-Public: 04046964181894
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K955585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2018

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 Expiration Date: 04/30/2021
• Device Catalogue Number: 352894
• Device Lot Number: 0061619866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1