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

Catalog Number	305900
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 when using the bd safetyglide¿, the device experienced needle separation from the syringe which remained in the patient.There are no reports of medical intervention notedly given to the patient.The following information was provided by the initial reporter.The customer stated: it was reported that needle came away from the syringe and remained in the patient.Needle came away from the syringe and remained in the patient.
Additional Manufacturer Narrative
Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Event or Problem Description
It was reported when using the bd safetyglide¿, the device experienced needle separation from the syringe which remained in the patient.There are no reports of medical intervention notedly given to the patient.The following information was provided by the initial reporter.The customer stated: it was reported that needle came away from the syringe and remained in the patient.Needle came away from the syringe and remained in the patient.
Event or Problem Description
It was reported when using the bd safetyglide¿, the device experienced needle separation from the syringe which remained in the patient.There are no reports of medical intervention notedly given to the patient.The following information was provided by the initial reporter.The customer stated: it was reported that needle came away from the syringe and remained in the patient.Needle came away from the syringe and remained in the patient.
Additional Manufacturer Narrative
Correction : after further evaluation of the complaint, it has been determined that the mdr 1213809-2022-00154 is a duplicate of 1213809-2022-00156 this supplemental is to cancel mdr 1213809-2022-00154.

• Brand Name: BD SAFETYGLIDE¿
• 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: 13875589
• Report Number: 1213809-2022-00154
• Device Sequence Number: 17309815
• Product Code: FMI
• UDI-Device Identifier: 00382903059003
• UDI-Public: 00382903059003
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2023

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: 10/31/2022
• Device Catalogue Number: 305900
• Device Lot Number: 7300870
• 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: 03/10/2022
• Supplement Date Received by Manufacturer: 05/30/2022; 02/03/2023
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 06/11/2022; 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2017
• 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