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

Catalog Number	305788
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 there was leakage at the luer connection of the bd luer-lok¿ syringe with detachable needle.There was no report of exposure, injury, or medical intervention noted.
Additional Manufacturer Narrative
Investigation summary: no sample or photo was received for investigation.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.Investigation conclusion: unable to determine a root cause.
Event or Problem Description
It was reported that there was leakage at the luer connection of the bd luer-lok¿ syringe with detachable needle.There was no report of exposure, injury, or medical intervention noted.
Event or Problem Description
It was reported that there was leakage at the luer connection of the bd luer-lok¿ syringe with detachable needle.There was no report of exposure, injury, or medical intervention noted.
Additional Manufacturer Narrative
Correction: due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device single use?: no.Device returned to manufacturer: no.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7682975
• Report Number: 8041187-2018-00257
• Device Sequence Number: 634424
• Product Code: FMI
• UDI-Device Identifier: 30382903057888
• UDI-Public: 30382903057888
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/17/2018

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: 09/30/2022
• Device Catalogue Number: 305788
• Device Lot Number: 7269238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 06/15/2018; 06/15/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 07/31/2018; 09/05/2018
• 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