MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 1 ML BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE; PISTON SYRINGE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305903
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Medical device type: a second device type of fmi is also applicable.Pma/510(k)#: there are two relevant pma/510k)s that apply to the device: k980580 syringe: needle: k951254.(b)(4).Investigation summary: one photo of a loose 1ml syringe was received and evaluated.It was observed there was a lengthwise crack outside the grad lines extending from the 0.2ml to the 0.4ml marking.The cracked barrel was rejectable per product specification.Potential root cause for the cracked barrel defect is associated with the assembly process.No corrective actions are necessary based on the defective rate identified.Batch 0142879 is considered in compliance with our product specification requirements.Furthermore, 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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: potential root cause for the cracked barrel defect is associated with the assembly process.(b)(4).No corrective actions are necessary based on the defective rate identified.Batch 0142879 is considered in compliance with our product specification requirements.
Event or Problem Description
It was reported that the 1 ml bd safetyglide" insulin syringe with attached needle experienced device damage/deformation while still considered operable.The following information was provided by the initial reporter: syringe broken.

• Brand Name: 1 ML BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE
• Common Device Name: PISTON SYRINGE; HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11316623
• Report Number: 1213809-2021-00075
• Device Sequence Number: 11447408
• Product Code: FMF
• UDI-Device Identifier: 00382903059034
• UDI-Public: 00382903059034
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2021

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: 04/30/2025
• Device Catalogue Number: 305903
• Device Lot Number: 0142879
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1