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

Model Number	305903
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple medical device types reported to be involved.The information for the additional device type is as follows: common device name: hypodermic single lumen needle.Medical device type: fmi.There were multiple pma / 510(k)#s reported to be involved.The information for each 510(k) number is as follows: pma / 510(k)#: k980580 (syringe).Pma / 510(k)#: k951254 (needle).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 the bd safetyglide¿ insulin syringe with attached needle plunger was damaged.The following information was provided by the initial reporter: "putter deformed plunger deformed.".
Additional Manufacturer Narrative
G5 is combination product?: no.H6: investigation summary: one photo was received showing a safetyglide blisterpak (p/n 305903) from batch #0262981, a loose 1ml syringe and a loose safetyglide needle.The photo was visually evaluated.There appeared to be no visual defects with the package or the needle.It was observed that the syringe's plunger rod was missing its thumbrest.It was unclear from the photo if the thumbrest was broken off or was a result of a short shot via improper molding.A physical sample is required for a more thorough evaluation and potential root cause determination.Since root cause could not be defined, corrective actions are not necessary at this time.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.H3 other text: see h10.
Event or Problem Description
It was reported that the bd safetyglide¿ insulin syringe with attached needle plunger was damaged.The following information was provided by the initial reporter: "putter deformed plunger deformed.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-12-02.H6: investigation summary one photo and one loose 1ml safetyglide syringe was received (p/n 305903).The sample was visually evaluated.The syringe was separated from the plunger rod and needle.The thumb rest was broken off of the plunger rod.The condition observed was non-conforming per product specification.Potential root cause for the broken plunger rod defect is associated with the assembly process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batch #0262981 is considered in compliance with our product specification requirements.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 that the bd safetyglide¿ insulin syringe with attached needle plunger was damaged.The following information was provided by the initial reporter: "putter deformed plunger deformed".

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11918015
• Report Number: 1213809-2021-00387
• Device Sequence Number: 3179358
• Product Code: FMF
• UDI-Device Identifier: 30382903059035
• UDI-Public: 30382903059035
• Combination Product (Y/N): Y
• Initial Reporter Country: TW
• PMA/510(K) Number: SEE H.10.
• 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): 12/16/2021

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: 08/31/2025
• Device Model Number: 305903
• Device Catalogue Number: 305903
• Device Lot Number: 0262981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 06/09/2021; 12/16/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 06/18/2021; 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2020
• 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