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

Catalog Number	305779
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.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.
Event or Problem Description
It was reported that bd luer -lok¿ syringe with detachable needle leaked.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Investigation summary: one returned sample received for investigation.The returned sample was subjected to visual inspection and hub leak test.Based on the visual inspection and hub leak test, the sample passed both acceptance criteria.During the visual inspection and hub leak test, there was no clogged needle observed.A lot history review was carried out and no related non conformance's were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.Investigation conclusion: based on the investigation finding, we are not able to confirm the defect.As such, we are unable to determine the root cause.
Event or Problem Description
It was reported that bd luer -lok¿ syringe with detachable needle leaked.No serious injury or medical intervention was reported.

• Brand Name: BD LUER -LOK¿ SYRINGE WITH DETACHABLE NEEDLE
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7890426
• Report Number: 8041187-2018-00361
• Device Sequence Number: 13495201
• Product Code: FMI
• UDI-Device Identifier: 00382903057795
• UDI-Public: 00382903057795
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/24/2018

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: 06/30/2022
• Device Catalogue Number: 305779
• Device Lot Number: 7176198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 09/24/2018
• 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