MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD SYRINGE¿ 3ML LL W/NDL ECLIPSE¿ 22X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305788
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Pma / 510(k)#: k980987 (syringe); k161170 (needle).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 bd syringe¿ 3ml ll w/ndl eclipse¿ 22x1 rb had a distorted stopper.
Event or Problem Description
It was reported bd syringe¿ 3ml ll w/ndl eclipse¿ 22x1 rb had a distorted stopper.
Additional Manufacturer Narrative
Investigation summary: 2 photos were returned for evaluation.From the returned photos it was unable to determine the non-conformance as stated.Root cause could not be determined as it was unable to observe the non-conformance from the returned photos.During the review of dhr, there is no abnormality observed on the visual inspection performed during the in- process inspection and out-going inspection.For the duration of 12 months, there is no quality notification raised on a similar non-conformance.

• Brand Name: BD SYRINGE¿ 3ML LL W/NDL ECLIPSE¿ 22X1 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8465846
• Report Number: 8041187-2019-00263
• Device Sequence Number: 11165718
• Product Code: FMI
• UDI-Device Identifier: 30382903057888
• UDI-Public: 30382903057888
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 04/01/2019

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 Expiration Date: 04/30/2022
• Device Catalogue Number: 305788
• Device Lot Number: 7114289
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 04/01/2019
• 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