MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE; PISTON SYRINGE

Model Number	305903
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	12/06/2021
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 that the rubber stopper was separated from the plunger while using bd safetyglide¿ insulin syringe with attached needle.There was no report of patient impact.The following information was provided by the initial reporter: "the needle core rubber stopper is separated from the syringe barrel.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2022-01-11.Investigation summary: one photo and one 1ml syringe were received from an unknown batch # (p/n 305903) and evaluated.The photo was of a loose 1ml syringe next to a plunger rod without a stopper.The stopper was inside the syringe bottomed out.There was also an activated safety glide needle attached to the syringe.There was no shield on the needle.The loose 1ml syringe received had an activated safety glide needle attached without a shield.Also, it had a stopper inside the syringe bottomed out.There were two vertical stress marks in the syringe observed.Upon disassembly it was observed that the stopper was jammed inverted inside the syringe.The condition observed was non-conforming per product specification.Potential root cause for the jammed stopper defect, plunger separation and barrel damage is associated with the assembly process.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) and corrective action could not be performed.H3 other text : see h10.
Event or Problem Description
It was reported that the rubber stopper was separated from the plunger while using bd safetyglide¿ insulin syringe with attached needle.There was no report of patient impact.The following information was provided by the initial reporter: "the needle core rubber stopper is separated from the syringe barrel.".
Additional Manufacturer Narrative
Becton dickinson and company's (bd) medication delivery solutions (mds) business unit will discontinue malfunction mdr reporting for certain device failures that have not caused or contributed to deaths or serious injuries in the past two years, and where the likelihood of a death or serious injury as a result of these malfunctions is remote.This decision follows fda guidelines (medical device reporting for manufacturers guidance for industry and food and drug administration staff issued nov 8, 2016, reference section 2.15).Bd notified fda of this decision on mar 3, 2025.Fda has reviewed and responded to bd¿s notification (reference fda document # (b)(4)) on march 7, 2025.This documentation is available in bd document management system (sap) as dir 10000690801.This supplemental mdr is being filed to document that the below device failure will no longer be considered a reportable malfunction mdr for the product family below: product family: safetyglide.Device failure: stopper separation.
Event or Problem Description
No additional information.

• Brand Name: BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE
• Common Device Name: PISTON SYRINGE
• 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: 13158214
• Report Number: 1213809-2021-00833
• Device Sequence Number: 19870422
• Product Code: FMF
• UDI-Device Identifier: 30382903059035
• UDI-Public: 30382903059035
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2025

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: Health Professional
• Device Model Number: 305903
• Device Catalogue Number: 305903
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2021
• Supplement Date Received by Manufacturer: 01/24/2022; Not provided
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 02/07/2022; 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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