MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD CONNECTOR LUER LOCK C45; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515202
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that there was a flow issue where injector/connector did no backprime into secondary infusion with a bd connector luer lock c45.The following information was provided by the initial reporter: material no.515202, batch no.1804105.It was reported that the injector/connector did not allow the rn to be able to backprime ns into a secondary infusion."interestingly enough¿ we had another phaseal issue overnight where the injector/connector did not allow the rn to be able to backprime ns into a secondary infusion.There is a safety report in--- 254045.The rn removed and replaced the phaseal with no success.What was concerning was that she was advised by pharmacy overnight to ¿spike and reprime yourself¿¿ which the rn did not do as it is not consistent with our safe handling standards.Ended up using this morning¿s dose and it was able to be back-primed.' connector is ref 515202, lot is 1804105.
Event or Problem Description
It was reported that there was a flow issue where injector/connector did no backprime into secondary infusion with a bd connector luer lock c45.The following information was provided by the initial reporter: material no.515202 batch no.1804105 it was reported that the injector/connector did not allow the rn to be able to backprime ns into a secondary infusion."interestingly enough¿ we had another phaseal issue overnight where the injector/connector did not allow the rn to be able to backprime ns into a secondary infusion.There is a safety report in--- 254045.The rn removed and replaced the phaseal with no success.What was concerning was that she was advised by pharmacy overnight to ¿spike and reprime yourself¿¿ which the rn did not do as it is not consistent with our safe handling standards.Ended up using this morning¿s dose and it was able to be back-primed.' connector is ref 515202, lot is 1804105.
Additional Manufacturer Narrative
Investigation summary: no photos or samples that display the reported condition were available for investigation.A device history review was performed for reported lot 1804105, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.Based on the available information we are not able to identify a root cause at this time.Complaints received for this defect and device will continue to be monitored by our quality team for signs of emerging trends.Evaluation of the connector design was completed by research and development team, and no design related potential causes were identified that could contribute to the flow issue failure mode that was observed.These complaints were also evaluated for use considerations and outside of clogging from undissolved drug during preparation, no other potential causes were identified from the product use.

• Brand Name: BD CONNECTOR LUER LOCK C45
• 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: 8619911
• Report Number: 3003152976-2019-00332
• Device Sequence Number: 1857687
• Product Code: ONB
• UDI-Device Identifier: 30382905152024
• UDI-Public: 30382905152024
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2019

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: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 515202
• Device Lot Number: 1804105
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 07/15/2019
• 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