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	01/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple classification types reported to be involved.The information for the additional device type is as follows: medical device type: fmi.Common device name: hypodermic single lumen needle.Pma / 510(k)#: k951254.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¿ insulin syringe with attached needle the plunger was deformed.The following information was provided by the initial reporter.The customer stated: the "plunger was deformed and can't be used.".
Event or Problem Description
It was reported when using the bd safetyglide¿ insulin syringe with attached needle the plunger was deformed.The following information was provided by the initial reporter.The customer stated: the "plunger was deformed and can't be used.".
Additional Manufacturer Narrative
H6: investigation summary three photos of 1ml syringes (p/n 305903) were visually evaluated.It was immediately observed in the photos that the stopper was missing from the plunger tip and instead jammed against the inside wall of the barrel.The observed condition was non-conforming per product specification.Potential root cause for the jammed stopper 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 #1097895 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.H3 other text : see h10.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2022-mar-08.H6: investigation summary: one sample and three photos (material 305903) were provided to our quality team for investigation.Through visual inspection, it was observed that the stopper was missing from the plunger tip and instead jammed against the inside wall of the barrel between the 0.06ml to the 0.28ml grad lines.The syringe also had two damage marks on the opposite side of grad lines.The condition observed was non-conforming per product specification.Potential root cause for the jammed stopper and damaged barrel defect are associated with the assembly process.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¿ insulin syringe with attached needle the plunger was deformed.The following information was provided by the initial reporter.The customer stated: the "plunger was deformed and can't be used.".

• 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: 13425264
• Report Number: 1213809-2022-00040
• Device Sequence Number: 17481346
• Product Code: FMF
• UDI-Device Identifier: 30382903059035
• UDI-Public: 30382903059035
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K980580
• 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): 03/18/2022

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: 03/31/2026
• Device Model Number: 305903
• Device Catalogue Number: 305903
• Device Lot Number: 1097895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 02/02/2022; 03/18/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 02/16/2022; 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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