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

Catalog Number	309571
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
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 4 bd luer-lok¿ syringes with attached needle had white foreign matter on the needles while still in the packaging.The following information was provided by the initial reporter: "reported issue: they have found 3-4 needles that have something "white" on the needle itself, rendering it useless.Where was the fm located? in the fluid path? inside or outside packaging? inside the package.What did the fm look like? (color / size, liquid like or powder like) white, looks like a paint substance.Was there any patient involvement? if yes, what is the patient outcome? are there any adverse events/serious injuries? no ¿ the substance was noticed prior to using for medication draw or any direct patient care.Was there a delay of, or change in, the course of treatment due to the event? new needle was pulled and used.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 04-may-2023.Investigation summary: one hundred twenty-five samples were provided to our quality team for investigation.Through visual inspection, it was observed that one sample has epoxy drip over on the needle.It most likely misfeeding of the cannulator induced the epoxy on the needle and not detected in the next processes.Based on the investigation with the returned sample analysis the symptom reported is confirmed.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 4 bd luer-lok¿ syringes with attached needle had white foreign matter on the needles while still in the packaging.The following information was provided by the initial reporter: "reported issue: they have found 3-4 needles that have something "white" on the needle itself, rendering it useless.Where was the fm located? in the fluid path? inside or outside packaging? inside the package what did the fm look like? (color / size, liquid like or powder like) white, looks like a paint substance.Was there any patient involvement? if yes, what is the patient outcome? are there any adverse events/serious injuries? no ¿ the substance was noticed prior to using for medication draw or any direct patient care.Was there a delay of, or change in, the course of treatment due to the event? new needle was pulled and used.".

• Brand Name: BD LUER-LOK¿ SYRINGE WITH ATTACHED 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 ; 8448235433
• MDR Report Key: 16923329
• Report Number: 1213809-2023-00502
• Device Sequence Number: 12492723
• Product Code: FMF
• UDI-Device Identifier: 00382903095711
• UDI-Public: 00382903095711
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/19/2023

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: 309571
• Device Lot Number: 2238253
• 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: 04/21/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2022
• 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