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

Model Number	305781
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Pma/510(k)#: k980987(syringe); k161170 (needle).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that bd luer-lok¿ syringes with detachable eclipse¿ needles leaked.This was discovered during use.The following information was provided by the initial reporter: material no: 305781, batch no: unknown.It was reported that leak was observed between the syringe and extension set.The leak was observed between bd eclipse and extension.
Additional Manufacturer Narrative
The following fields have been updated with corrections: d.3.Medical device manufacturer: tuas.
Event or Problem Description
It was reported that bd luer-lok¿ syringes with detachable eclipse¿ needles leaked.This was discovered during use.The following information was provided by the initial reporter: material no: 305781, batch no: unknown.It was reported that leak was observed between the syringe and extension set.The leak was observed between bd eclipse and extension.
Additional Manufacturer Narrative
H.6.Investigation summary: one syringe was received by our quality team for evaluation.Upon visual inspection, no damage was observed at the syringe collar thread or the syringe tip.Leak testing was also performed and no leakage was observed.The incident could not be verified.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the investigation, no root cause could be determined due to the sample passing visual inspection and leak testing.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.H3 other text : see section h.10.
Event or Problem Description
It was reported that bd luer-lok¿ syringes with detachable eclipse¿ needles leaked.This was discovered during use.The following information was provided by the initial reporter: material no: 305781 batch no: unknown it was reported that leak was observed between the syringe and extension set.The leak was observed between bd eclipse and extension.

• Brand Name: BD LUER-LOK¿ SYRINGES WITH DETACHABLE ECLIPSE¿ NEEDLES
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore UT 84070
• MDR Report Key: 9279844
• Report Number: 8041187-2019-00891
• Device Sequence Number: 14287278
• Product Code: FMI
• UDI-Device Identifier: 30382903057819
• UDI-Public: 30382903057819
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: SEE H.10
• 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,Followup
• Report Date (Section B): 02/06/2020

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 Model Number: 305781
• Device Catalogue Number: 305781
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 10/21/2019; 10/21/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 12/06/2019; 02/06/2020
• 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
• Patient Age: 4 DA