MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 22 G X 1 1/2 IN. BD ECLIPSE¿ 3 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE; BLOOD COLLECTION DEVICE

Catalog Number	305783
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.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.This device has two 510k # k980987(syringe); k161170 (needle).
Event or Problem Description
It was reported that the 22 g x 1 1/2 in.Bd eclipse¿ 3 ml bd luer-lok¿ syringe with detachable needle leaked.There was no report of exposure, injury or medical intervention.
Additional Manufacturer Narrative
Due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: yes.
Event or Problem Description
"it was reported that the 22 g x 1 1/2 in.Bd eclipse¿ 3 ml bd luer-lok¿ syringe with detachable needle leaked.There was no report of exposure, injury or medical intervention.".
Event or Problem Description
It was reported that the 22 g x 1 1/2 in.Bd eclipse¿ 3 ml bd luer-lok¿ syringe with detachable needle leaked.There was no report of exposure, injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: no sample or photo was returned for investigation.Unable to perform dhr as a lot number was unavailable.Investigation conclusion: unable to determine a root cause.

• Brand Name: 22 G X 1 1/2 IN. BD ECLIPSE¿ 3 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE
• Common Device Name: BLOOD COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7685757
• Report Number: 8041187-2018-00256
• Device Sequence Number: 13770378
• Product Code: FMI
• UDI-Device Identifier: 00382903057832
• UDI-Public: 00382903057832
• 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
• 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: 11/30/2022
• Device Catalogue Number: 305783
• Device Lot Number: 7362021
• 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: 07/13/2018
• Supplement Report FDA Received Date: 07/31/2018; 09/11/2018
• 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