MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 30 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE; SYRINGE AND NEEDLE

Catalog Number	305778
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Fda notified: the initial reporter also notified the fda on 01/08/2019, medwatch # mw5082288.Device expiration date: unknown.Device manufacture date: unknown.Pma / 510(k)#: k941562 (syringe); k010188 (needle).Medical device type: fmi / fmf.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 a 30 g x 1/2 in.Bd eclipse¿ 1 ml bd luer-lok¿ syringe with detachable needle had a loose plunger and discharged medication from the plunger.
Event or Problem Description
It was reported that a 30 g x 1/2 in.Bd eclipse¿ 1 ml bd luer-lok¿ syringe with detachable needle had a loose plunger and discharged medication from the plunger.
Additional Manufacturer Narrative
Investigation summary: since no samples and photos displaying the reported condition were received no defects can be confirmed.A review of the device history record could not be performed as a lot number was not provided for this incident.Root cause could not be determined as there is no sample returned for investigation.For the duration of the last 12 months, there was no quality notification raised for a similar non-conformance.

• Brand Name: 30 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE
• Common Device Name: SYRINGE AND NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8317247
• Report Number: 8041187-2019-00137
• Device Sequence Number: 11297368
• Product Code: FMI
• UDI-Device Identifier: 00382903057788
• UDI-Public: 00382903057788
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/15/2019

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 Catalogue Number: 305778
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 02/07/2019
• Supplement Report FDA Received Date: 02/15/2019
• 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