MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ NEEDLE 25 G X 1 IN. WITH DETACHABLE 3 ML BD LUER-LOK¿ SYRINGE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305787
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown.There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: 510k#:k161170 medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd eclipse¿ needle 25 g x 1 in.With detachable 3 ml bd luer-lok¿ syringe leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the consumer the medication syringes are leaking.  certain bd 3 ml syringes are either not compatible with bd maxzero connector or defective.Pharmacy has received two reports this week of medication syringes leaking during administration at the site of the syringe leur lock tip:maxzero connection.Upon preliminary investigation, it is determined that certain bd 3 ml syringes will consistently result in leakage during administration.
Additional Manufacturer Narrative
H6: investigation summary no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.H3 other text : see h10.
Event or Problem Description
It was reported while using bd eclipse¿ needle 25 g x 1 in.With detachable 3 ml bd luer-lok¿ syringe leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the consumer the medication syringes are leaking.  certain bd 3 ml syringes are either not compatible with bd maxzero connector or defective.Pharmacy has received two reports this week of medication syringes leaking during administration at the site of the syringe leur lock tip:maxzero connection.Upon preliminary investigation, it is determined that certain bd 3 ml syringes will consistently result in leakage during administration.

• Brand Name: BD ECLIPSE¿ NEEDLE 25 G X 1 IN. WITH DETACHABLE 3 ML BD LUER-LOK¿ SYRINGE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14595113
• Report Number: 8041187-2022-00283
• Device Sequence Number: 5517266
• Product Code: FMI
• UDI-Device Identifier: 00382903057870
• UDI-Public: 00382903057870
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 07/13/2022

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 Catalogue Number: 305787
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown