MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD NEEDLE ECLIPSE 23X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305762
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported when using the bd needle eclipse 23x1 rb, the user experienced difficulty engaging the safety mechanism.The following information was provided by the initial reporter.The customer stated: it was reported that it is not easy to cap the needle after administration, while holding children.Customer reported that the new needles that they have received do not close easily after administration.It makes it tough to cap the needle after administration one handed as you are holding children.
Additional Manufacturer Narrative
H6: investigation summary: one photo was received by our quality team for evaluation.Only the top web was shown in the photo and therefore the team is unable to observe the reported defect.A device history record could not be evaluated as the lot number is unknown.
Event or Problem Description
The following information was provided by the initial reporter.The customer stated: it was reported that it is not easy to cap the needle after administration, while holding children.Customer reported that the new needles that they have received do not close easily after administration.It makes it tough to cap the needle after administration one handed as you are holding children.

• Brand Name: BD NEEDLE ECLIPSE 23X1 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13548675
• Report Number: 8041187-2022-00085
• Device Sequence Number: 5036922
• Product Code: FMI
• UDI-Device Identifier: 00382903057627
• UDI-Public: 00382903057627
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 03/04/2022

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: 305762
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 03/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown