MAUDE Adverse Event Report: BECTON DICKINSON, S.A. INJECTOR LUER LOCK N35C; INTRAVASCULAR ADMINISTRATION SET

Model Number	515004
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2020
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.(b)(4).
Event or Problem Description
It was reported the injector luer lock n35c experienced needle exposure - defective injector.The following information was provided by the initial reporter and translated from (b)(6) to english: "the three-way connecta with q-syte leaks / tears resulting in blood loss of the patient." device safety mechanism failed to secure needle which can result in an exposed needle.
Additional Manufacturer Narrative
H.6.Investigation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for lot 1805106, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Based on the available information, we are not able to identify a root cause related to our manufacturing process at this time.
Event or Problem Description
It was reported the injector luer lock n35c experienced needle exposure - defective injector.The following information was provided by the initial reporter and translated from french to english: "the three-way connecta with q-syte leaks / tears resulting in blood loss of the patient." device safety mechanism failed to secure needle which can result in an exposed needle.

• Brand Name: INJECTOR LUER LOCK N35C
• 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: 10216219
• Report Number: 3003152976-2020-00280
• Device Sequence Number: 16750595
• Product Code: ONB
• UDI-Device Identifier: 30382905150044
• UDI-Public: 30382905150044
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

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 Expiration Date: 10/31/2020
• Device Model Number: 515004
• Device Catalogue Number: 515004
• Device Lot Number: 1805106
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 08/06/2020
• 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