MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305789
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple medical device types reported to be involved.The information for the additional device type is as follows: common device name: piston syringe.Medical device type: fmf.There were multiple pma / 510(k)#s reported to be involved.The information for each 510(k) number is as follows: pma / 510(k)#: k161170 (needle).Pma / 510(k)#: k941562 (syringe).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 the plunger of the bd luer-lok¿ syringe with detachable bd eclipse¿ needle became "stuck" during the ppd skin test, and the solution could not be pushed out.This occurred on 2 separate occasions, but the dates and/or patient information are unknown.The following information was provided by the initial reporter: "medical assistant was trying to give a ppd skin test.She was able to draw up the solution without a problem.When it came time to give the injection, when she pushed the syringe in, the syringe was stuck and would not push out the solution.Ma took out the needle and tried to push out solution with out sticking the employee and it was still stuck and unable to get solution out.Ma tried with another needle and syringe from the same box and same problem occurred again.".
Event or Problem Description
It was reported that the plunger of the bd luer-lok¿ syringe with detachable bd eclipse¿ needle became "stuck" during the ppd skin test, and the solution could not be pushed out.This occurred on 2 separate occasions, but the dates and/or patient information are unknown.The following information was provided by the initial reporter: "medical assistant was trying to give a ppd skin test.She was able to draw up the solution without a problem.When it came time to give the injection, when she pushed the syringe in, the syringe was stuck and would not push out the solution.Ma took out the needle and tried to push out solution with out sticking the employee and it was still stuck and unable to get solution out.Ma tried with another needle and syringe from the same box and same problem occurred again.".
Additional Manufacturer Narrative
H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10015233
• Report Number: 8041187-2020-00235
• Device Sequence Number: 14216223
• Product Code: FMI
• UDI-Device Identifier: 30382903057895
• UDI-Public: 30382903057895
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10.
• 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,Followup
• Report Date (Section B): 05/14/2020

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: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: 305789
• Device Catalogue Number: 305789
• Device Lot Number: 9267437
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/10/2020
• Supplement Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 05/14/2020
• 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