MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD LUER-LOK; PISTON SYRINGE

Catalog Number	302832
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd syringe 30ml ll s/c 56 had leakage.The following information was provided by the initial reporter: material #302832.Batch #5212060.Verbatim: as per the report: rn went to administer doxorubicin that was made from pharmacy.Nurse went to push the medication into patients iv.Doxoubicin spilled out of the other side of the syringe and spilled onto the blanket that the patient had on him.Another report stated: primary rn gave doxorubicin iv push via mediport with good blood return.Upon completion of first syringe of doxorubicin, primary rn placed syringe in chemo bin.Pt noticed orange tint on her shoe.Primary rn presumed tint to be doxorubicin spill.The impacted product is sequestered and we would like to send it back for a quality review.Can you please advise next steps.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation.It was reported that doxorubicin leaked from the opposite side of the syringe.To support the investigation, one hundred eighty-four samples in sealed blister packaging were received for evaluation by the quality team.A visual inspection of all samples revealed no defects or imperfections.Thirty-two samples were randomly selected for functional assessment; each underwent leak testing and passed.A device history record (dhr) review was completed for material number 302832, lot 5212060.The review did not identify any quality issues during production that could have contributed to the reported condition.There were no related quality notifications, and all processes and final inspections complied with specification requirements.To date, no similar events have been reported for this lot.Based on the investigation and analysis of the returned samples, the customer¿s reported condition could not be confirmed.

• Brand Name: BD LUER-LOK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23797856
• Report Number: 1911916-2025-00794
• Device Sequence Number: 12149214
• Product Code: FMF
• UDI-Device Identifier: 00382903028320
• UDI-Public: (01)00382903028320(10)5212060
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: 302832
• Device Lot Number: 5212060
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/13/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown