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

Catalog Number	305788
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma / 510(k)#: k980987(syringe); k161170 (needle).(b)(6).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 prior to use it was noticed that the stopper was deformed with a bd syringe 3ml ll w/ndl eclipse 22x1 rb.The following information was provided by the initial reporter: distorted stopper.
Event or Problem Description
It was reported that prior to use it was noticed that the stopper was deformed with a bd syringe 3ml ll w/ndl eclipse 22x1 rb.The following information was provided by the initial reporter: distorted stopper.
Additional Manufacturer Narrative
Investigation summary: 2 photos were received for investigation and unable to observe distorted stopper from the photos.Unable to observe distorted stopper from the received photos.Actual sample was not returned for evaluation.Root cause could not be determined.A device history record review was performed and showed no non-conformance's associated with this issue during the production of this batch.

• 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: 8732666
• Report Number: 8041187-2019-00487
• Device Sequence Number: 2572757
• 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): 07/08/2019

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: 06/07/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 07/08/2019
• 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