MAUDE Adverse Event Report: BECTON DICKINSON INJECTOR N35-O MULTI; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515053
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported, luer lock breakage.Event description: during compounding of cisplatin.New cisplatin vial new vial protector p28 lot: 2502706 new injector (multipack) lot: 2501301 new syringe monoject.Vial protector attached to new cisplatin vial.Air added to syringe.Injector applied.Injector & syringe attached down onto vial protector while trying to inject air - met with resistance.Tech added a little more pressure.Syringe broke from injector, but injector remained on vial protector & vial.Cisplatin flowed up through the open injector and onto the bsc.Exposure to hazardous drugs.Additional information 1.Did the expansion chamber inflate when adding air into the vial? no 2.What was the volume of medication to be withdrawn? 50ml 3.How much air was injected before meeting resistance? 50ml 4.Did the luer of the injector break? or did only the syringe break off? the syringe broke at the luer lock 5.I s the syringe a standard luer lock? yes 6.Is the syringe a bd product? if yes, what is the material information? unclear which syringe was being used at the time.1.Was the appropriate ppe in use when the exposure occurred? yes.2.Was there any intervention required for the healthcare professional as a result of the exposure? no.3.Was the medication prepared under a hood? yes.Option:.
Additional Manufacturer Narrative
H11 -a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: it was reported that the luer lock of the n35-o injector broke when attempting to add air to the protector.No injector samples were received for evaluation.A device history review was completed for the reported lot 2501301, and no deviations or nonconformances were identified during the manufacturing process that could have contributed to the reported concern.Three retained samples from injector lot 2501301 were examined as part of the investigation.All products underwent visual inspection, and no damage or related defects were observed.Dimensional testing, including verification of the luer thread, confirmed that all critical dimensions were within specification.Based on the available information, a definitive root cause could not be identified at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: INJECTOR N35-O MULTI
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22636168
• Report Number: 3003152976-2025-00388
• Device Sequence Number: 20830636
• Product Code: ONB
• UDI-Device Identifier: 00382905150531
• UDI-Public: (01)00382905150531(10)2501301
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K140591
• 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): 12/12/2025

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: 515053
• Device Lot Number: 2501301
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown