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

Catalog Number	309645
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.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 bd luer lok¿ tip with precisionglide¿ needle was exposed in the package due to the broken cap.The following was received by the initial reporter: what is the issue you experienced?: one (1) syringe needle was exposed in the package due to the broken cap.
Additional Manufacturer Narrative
H6: investigation summary: seven photos were provided to our quality team for investigation.Through visual inspection, it was observed that the needle shield is broken and about 1/3 part of the needle exposed through shield.Potential root cause for the shield damaged defect is associated with the assembly process.These defects are occurring below an expected rate so no corrective actions will be made at this time.A device history record review showed no rejected inspections or quality issues during the production of the provided batch number that could have contributed to the reported defect.
Event or Problem Description
It was reported that the bd luer lok¿ tip with precisionglide¿ needle was exposed in the package due to the broken cap.The following was received by the initial reporter: what is the issue you experienced?: one (1) syringe needle was exposed in the package due to the broken cap.

• Brand Name: BD LUER LOK¿ TIP WITH 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17547215
• Report Number: 1213809-2023-00858
• Device Sequence Number: 6714071
• Product Code: FMF
• UDI-Device Identifier: 30382903096450
• UDI-Public: (01)30382903096450
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2023

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: 309645
• Device Lot Number: 2221883
• 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: 08/01/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2022
• 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