MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEEDLE ECLIPSE 22X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305763
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter facility: the user facility address is not available, the corporate headquarters information was used instead.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It has been reported that one needle eclipse 22x1-1/2 rb has been found with the safety mechanism detaching.The following has been provided by the initial reporter: it was reported that a needle guard that fell off an eclipse needle.I received of a report of a needle guard that fell off an eclipse needle.They have retained the device.Needle guard fell off of needle while administering medication.Bd eclipse needle 22 g x 1.5 mm x 40 mm needle; manufactured by bd; lot #: 8333651; exp 11/30/2023.Name of device/supply/implant involved: bd eclipse needle.Name of manufacturer : bd.
Event or Problem Description
It has been reported that one needle eclipse 22x1-1/2 rb has been found with the safety mechanism detaching.The following has been provided by the initial reporter: it was reported that a needle guard that fell off an eclipse needle.I received of a report of a needle guard that fell off an eclipse needle.They have retained the device.Needle guard fell off of needle while administering medication.Bd eclipse needle 22 g x 1.5 mm x 40 mm needle; manufactured by bd; lot #: 8333651; exp 11/30/2023.Name of device/supply/implant involved: bd eclipse needle name of manufacturer : bd.
Additional Manufacturer Narrative
Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
Additional Manufacturer Narrative
Correction: added date of event and facility address.The following information has been updated: b.3.Date of event: (b)(6) 2019.E.1.Initial reporter phone#: (b)(6).E.1.Initial reporter address 1: (b)(6).E.1.Initial reporter city: (b)(6).E.1.Initial reporter state: (b)(6).E.1.Initial reporter zip: (b)(6).H3 other text : see h.10.
Event or Problem Description
It has been reported that one needle eclipse 22x1-1/2 rb has been found with the safety mechanism detaching.The following has been provided by the initial reporter: it was reported that a needle guard that fell off an eclipse needle.I received of a report of a needle guard that fell off an eclipse needle.They have retained the device.Needle guard fell off of needle while administering medication.Bd eclipse needle 22 g x 1.5 mm x 40 mm needle; manufactured by bd; lot #: 8333651; exp 11/30/2023.Name of device/supply/implant involved: bd eclipse needle.Name of manufacturer : bd.

• Brand Name: NEEDLE ECLIPSE 22X1-1/2 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9106613
• Report Number: 8041187-2019-00747
• Device Sequence Number: 2131432
• Product Code: FMI
• UDI-Device Identifier: 30382903057635
• UDI-Public: 30382903057635
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2019

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: 11/30/2023
• Device Catalogue Number: 305763
• Device Lot Number: 8333651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 09/05/2019; 09/05/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 09/26/2019; 10/10/2019
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown