MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ CONNECTOR LUER LOCK (C35); INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515200
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident and a root cause could be determined.A device history review could not be completed as no batch number was provided.Examination of the product involved may provide clarification as to the cause for the reported failure.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.Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no information or sample was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.Root cause description: undetermined.No lot information or sample available.Rationale: no lot information or sample available.
Event or Problem Description
It was reported that bd phaseal¿ connector luer lock (c35) leaked.This was discovered during use.The following information was provided by the initial reporter: the following was submitted by the sales rep: disconnects & leaks when using phaseal on long term infusions.2 incidents reported of n35 coming disconnected from alaris tubing set.Drug leaked from tubing once n35 was disconnected.Re-education in pharmacy to tighten n35 to tubing set properly.Went over difference between fixed collar and sliding collar.Met with nurse educator and went over clamping and "pull, pause, turn, pull when disconnecting n35 from c45.Per communication with sales rep: after a 24 hour infusion, the n35 injector was manually disconnected from the c45 connector.Immediately after disconnect, there was a leak that came thru the membrane of the c45 connector.

• Brand Name: BD PHASEAL¿ CONNECTOR LUER LOCK (C35)
• 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: 9366738
• Report Number: 3003152976-2019-00804
• Device Sequence Number: 16775588
• Product Code: ONB
• UDI-Device Identifier: 30382905152000
• UDI-Public: 30382905152000
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K123213
• 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): 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 515200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 11/22/2019
• 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