MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE¿ NEEDLE1-ML SYRINGE WITH 25-G X 5/8-IN; 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	02/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: pma / 510(k)#:k951254.
Event or Problem Description
It was reported while using bd safetyglide¿ 1-ml syringe with 25-g x 5/8-in needle a stopper was found to be deformed.There was no report of patient impact.The following information was provided by the initial reporter: stopper deformation.
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-07.Investigation summary: one physical sample and one photo of a 1ml slip tip syringe with safetyglide 25x5/8 needle (p/n 305903) were received.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 and the plunger rod.The observed condition is 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 #0325431 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.
Event or Problem Description
It was reported while using bd safetyglide¿ 1-ml syringe with 25-g x 5/8-in needle a stopper was found to be deformed.There was no report of patient impact.The following information was provided by the initial reporter: stopper deformation.

• Brand Name: BD SAFETYGLIDE¿ NEEDLE1-ML SYRINGE WITH 25-G X 5/8-IN
• 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: 13550198
• Report Number: 1213809-2022-00082
• Device Sequence Number: 17439976
• 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
• Report Date (Section B): 03/16/2022

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: 11/30/2025
• Device Model Number: 305903
• Device Catalogue Number: 305903
• Device Lot Number: 0325431
• 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: 02/07/2022
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2020
• 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