MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE WITH THE BD PRECISIONGLIDE¿ NEEDLE; PISTON SYRINGE

Catalog Number	309572
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone#: unknown.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 an unspecified number of bd luer-lok¿ syringes with the bd precisionglide¿ needle had issues connecting to the syringe during use and leaked medication as a result.The following information was provided by the initial reporter: "others would not seal correctly where needle is threaded to syringe causing difficulty drawing meds and losing meds when administering (so not knowing if proper dose was received).".
Event or Problem Description
It was reported that an unspecified number of bd luer-lok¿ syringes with the bd precisionglide¿ needle had issues connecting to the syringe during use and leaked medication as a result.The following information was provided by the initial reporter: "others would not seal correctly where needle is threaded to syringe causing difficulty drawing meds and losing meds when administering (so not knowing if proper dose was received).".
Additional Manufacturer Narrative
A device history review was conducted for lot number 2048232.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.One photo was provided to our quality team for investigation.Based on the investigation and with no physical sample analysis the symptom reported by the customer could not be confirmed.H3 other text : see h10.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH THE BD PRECISIONGLIDE¿ 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: 15800081
• Report Number: 1213809-2022-00991
• Device Sequence Number: 3010523
• Product Code: FMF
• UDI-Device Identifier: 00382903095728
• UDI-Public: (01)00382903095728
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• 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): 01/11/2023

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 Catalogue Number: 309572
• Device Lot Number: 2048232
• 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: 10/21/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• 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