MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305921
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event is unknown.The date received by manufacturer has been used for this field.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 needle pulled out of hub while using bd safetyglide¿ needle.No patient impact reported.The following information was provided by the initial reporter: upon engaging the safety needle guard to cover the used needle, the needle detached from the securement base.No injury to staff or patient.
Event or Problem Description
It was reported that needle pulled out of hub while using bd safetyglide¿ needle.No patient impact reported.The following information was provided by the initial reporter: upon engaging the safety needle guard to cover the used needle, the needle detached from the securement base.No injury to staff or patient.
Additional Manufacturer Narrative
H6: investigation summary: two photos were provided to our quality team for investigation.Through visual inspection, it was observed that cannula disconnected from the hub.Based on the investigation with the photo sample analysis the symptom reported is confirmed.Since no physical sample displaying the reported condition was received a potential root cause could not be defined.A device history record review was completed for provided lot number 1204567.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

• Brand Name: BD SAFETYGLIDE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15136319
• Report Number: 1213809-2022-00444
• Device Sequence Number: 5110623
• Product Code: FMI
• UDI-Device Identifier: 00382903059218
• UDI-Public: 00382903059218
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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: 06/30/2026
• Device Catalogue Number: 305921
• Device Lot Number: 1204567
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• 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