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

Model Number	305903
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
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 2 bd safetyglide¿ insulin syringes with attached needle had damaged, "melted" plunger rods.The following information was provided by the initial reporter: "plunger melted".

• 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: 13004636
• Report Number: 1213809-2021-00814
• Device Sequence Number: 4216443
• Product Code: FMF
• UDI-Device Identifier: 30382903059035
• UDI-Public: 30382903059035
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: SEE H10
• 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
• Report Date (Section B): 11/30/2021

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: 03/31/2026
• Device Model Number: 305903
• Device Catalogue Number: 305903
• Device Lot Number: 1097895
• 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: 11/16/2021
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• 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