MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 10ML S/T 200 S/C; PISTON SYRINGE

Catalog Number	303134
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 303134, batch#: 4078418.It was reported that the bd syringe 10ml s/t 200 s/c leaked.The following information was provided by the initial reporter: describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.The patient did not receive the full dose of chemotherapy but was unharmed.Could you please confirm if syringe lot: 4078418 is also experiencing leakage issues? leaks have been reported with multiple sizes of spinal needles and it is unknown if all these syringes were from the same lot during these events.Could you please specify the exact location where the leak occurred on the product? leaking occurs from the hub of the spinal needle, around the slip-tip syringe.Clinicians state that they have to forcefully press the slip tip syringe into the hub of the needle to prevent leaking, and that this amount of force is greater than they have had to use to achieve a secure connection prior to these events.Customer response on (b)(6) 2024.1.Can you please provide an exact date of event in format (mm-dd-yyyy) for lot#: 4078418? a.10-23-2024.Could you please confirm the type of hazardous drug (chemo/radiation) or provide the name of the drug that caused contamination? this information will help us send the appropriate shipping label.Methotrexate.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Nine samples were provided to our quality team for investigation.All nine samples were tested for leakage with no leakage observed on any of the syringes received.The condition observed is acceptable per product specification.The reported defect was not identified in the samples received, so no corrective action is required at this time.Furthermore, a device history record review was completed for provided lot number 4078418.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.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 monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: BD SYRINGE 10ML S/T 200 S/C
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20898533
• Report Number: 1213809-2024-00940
• Device Sequence Number: 5006413
• Product Code: FMF
• UDI-Device Identifier: 00382903031344
• UDI-Public: (01)00382903031344(11)240318(17)290228(10)4078418
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2025

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: Health Professional
• Device Catalogue Number: 303134
• Device Lot Number: 4078418
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 02/16/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown