MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML S/T W/NDL SFTYGLD 25X5/8 RB; PISTON SYRINGE

Catalog 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	09/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that syringe 1ml s/t w/ndl sftygld 25x5/8 rb stopper was deformed.The following information was provided by the initial reporter: stopper deformation.
Additional Manufacturer Narrative
H.6.Investigation: one photo was received and evaluated.The photo showed a loose 1ml s/t syringe next to an opened safetyglide combo package from batch #1097894 (p/n (b)(6)).The syringe was observed to have its stopper jammed between the plunger rod and barrel wall.Potential root cause for the jammed stopper defect is 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.H3 other text : see h.10.
Event or Problem Description
It was reported that syringe 1ml s/t w/ndl sftygld 25x5/8 rb stopper was deformed.The following information was provided by the initial reporter: stopper deformation.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 12/2/2021.H.6.Investigation: one sample and one photo was received and evaluated.The sample was a loose 1ml syringe (p/n 305903) with a detached safety glide needle.The syringe was observed to have its stopper jammed between the plunger rod and barrel wall.There are distended marks where the jammed stopper was in the barrel.The distended marks are near the graduated scale lines from the 1.5 to the 3.0ml.Also, from where the 1.0 to the 3.2ml numeral are printed.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 1097894 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 h.10.
Event or Problem Description
It was reported that syringe 1ml s/t w/ndl sftygld 25x5/8 rb stopper was deformed.The following information was provided by the initial reporter: stopper deformation.

• Brand Name: SYRINGE 1ML S/T W/NDL SFTYGLD 25X5/8 RB
• 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: 12616544
• Report Number: 1213809-2021-00707
• Device Sequence Number: 18035500
• Product Code: FMI
• UDI-Device Identifier: 00382903059034
• UDI-Public: 00382903059034
• 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): 12/21/2021

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 Catalogue Number: 305903
• Device Lot Number: 1097894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 11/03/2021; 12/21/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 11/29/2021; 01/05/2022
• 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