MAUDE Adverse Event Report: BECTON DICKINSON, S.A. INFUSION ADAPTER C100-O MULTI; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515079
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown the customer's address is unknown.(b)(6) has been used as a default.Device manufacture date: unknown.Investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Investigation conclusion: complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.Root cause description: based on the available information we are not able to identify a root cause at this time.
Event or Problem Description
It was reported that infusion adapter c100-o multi had a chemo spill.This was discovered during use.The following information was provided by the initial reporter: material no: unknown (provided c100), batch no: unknown.It was reported that there was a chemo spill due to a c100 falling out of the bag while mixing.

• Brand Name: INFUSION ADAPTER C100-O MULTI
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 10243240
• Report Number: 3003152976-2020-00291
• Device Sequence Number: 19571036
• Product Code: ONB
• UDI-Device Identifier: 00382905150791
• UDI-Public: 00382905150791
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2020

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: Other
• Device Catalogue Number: 515079
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other