MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD LUER-LOK¿ SYRINGE WITH BD SAFETYGLIDE¿ NEEDLE; PISOTN SYRINGE

Catalog Number	305908
Medical Device Problem Codes	Defective Component (2292); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 the stopper in the bd luer-lok¿ syringe with bd safetyglide¿ needle was deformed/twisted, causing an inaccurate volume of medication to be dispensed.The following information was provided by the initial reporter: "on 01sep2023, a defective syringe was encountered while performing a laboratory test.The rubber stopper in the barrel was morphed/twisted which caused an inaccurate volume to be dispensed.".
Additional Manufacturer Narrative
Our quality engineer inspected the one photo submitted for evaluation.The reported issue of stopper defective / damaged was confirmed upon inspection of the sample photo.Analysis of the sample photo showed that the stopper of the syringe was jammed.Bd determined that the cause of the failure was related to our assembly process.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH BD SAFETYGLIDE¿ NEEDLE
• Common Device Name: PISOTN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17821693
• Report Number: 1920898-2023-00656
• Device Sequence Number: 16729897
• Product Code: MEG
• UDI-Device Identifier: 30382903059080
• UDI-Public: 30382903059080
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2024

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: 12/31/2024
• Device Catalogue Number: 305908
• Device Lot Number: 0154842
• 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: 09/12/2023
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2020
• 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