MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305787
Medical Device Problem Code	Shielding Failure (1568)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that syringe 3ml ll w/ndl eclipse 25x1 rb needle went through the shield.The following information was provided by the initial reporter: it was reported needle though the shield.
Event or Problem Description
It was reported that syringe 3ml ll w/ndl eclipse 25x1 rb needle went through the shield.The following information was provided by the initial reporter: it was reported needle though the shield.
Additional Manufacturer Narrative
Investigation summary: two photos were received by our quality team for evaluation.From the photos, the needle pierced through the shield was observed.However, this is not an eclipse product that is manufactured by bd tuas.A device history record could not be evaluated as the lot number is unknown.Therefore, the root cause of this incident cannot be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 12086593
• Report Number: 8041187-2021-00546
• Device Sequence Number: 19923110
• Product Code: FMI
• UDI-Device Identifier: 00382903057870
• UDI-Public: 00382903057870
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 305787
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1