MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD ECLIPSE¿ SAFETY NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305891
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd eclipse¿ safety needle a needle detached from the hub.There was no report of patient impact.The following information was provided by the initial reporter: issue with connection of safety needle to syringes.Not secure enough.Incident where needle has come free and pricked a staff member (this was during a demonstration of the fault in the office environment- not needle-stick injury, near miss).
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were corrected: d10: device available for eval no, d10: returned to manufacturer on: na.H6: investigation summary a device history record review was completed for provided lot number 2109009.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As samples were unavailable for return, twenty retained samples of the same lot number were obtained for evaluation by our quality engineer team.The retained samples were examined and no issues with the safety mechanism were identified, it was possible to correctly activate the safety mechanisms by following the guidelines in the instructions for use.Based on the investigation results, an exact cause related to the manufacturing process could not be identified for this reported incident.H3 other text : see h10.
Event or Problem Description
It was reported while using bd eclipse¿ safety needle a needle detached from the hub.There was no report of patient impact.The following information was provided by the initial reporter: issue with connection of safety needle to syringes.Not secure enough.Incident where needle has come free and pricked a staff member (this was during a demonstration of the fault in the office environment- not needle-stick injury, near miss).

• Brand Name: BD ECLIPSE¿ SAFETY NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13342466
• Report Number: 3002682307-2022-00013
• Device Sequence Number: 4164524
• Product Code: FMI
• UDI-Device Identifier: 50382903058919
• UDI-Public: 50382903058919
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K100209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2022

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 Expiration Date: 08/31/2026
• Device Model Number: 305891
• Device Catalogue Number: 305891
• Device Lot Number: 2109009
• 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: 01/05/2022
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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