MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INJECTOR LUER LOCK N35

Catalog Number	515001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 leaking was found from a bd phaseal¿ injector luer lock n30c.The bd phaseal¿ injector luer lock n30c was pulled out, after the drug was transferred into the iv bag, leaving the needle left unprotected.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Results: bd received four photographs from the customer facility for investigation.The pictures showed the needle exposed.This takes place as the injector is still active while disconnection.The grips are out of place.Additionally, two retention samples were selected for evaluation, and the customer's indicated failure mode for leakage and broken safety shield was not observed as all samples met specifications.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure mode.The root cause is considered a misuse of the defect.
Additional Manufacturer Narrative
Date of event and received by manufacturer corrections.The date of event and date received by manufacturer fields have been updated to reflect the corrected dates as indicated below: date of event: (b)(6) 2017.Date received by manufacturer: 11/22/2017.

• Brand Name: BD PHASEAL¿ INJECTOR LUER LOCK N35
• Common Device Name: INJECTOR
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7122579
• Report Number: 3003152976-2017-00196
• Device Sequence Number: 11059300
• Product Code: ONB
• UDI-Device Identifier: 30382905150013
• UDI-Public: 30382905150013
• Combination Product (Y/N): N
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2018

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 Expiration Date: 01/31/2020
• Device Catalogue Number: 515001
• Device Lot Number: 1706106
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 11/29/2017; 11/22/2017
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 01/03/2018; 02/20/2018
• 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