MAUDE Adverse Event Report: BECTON DICKINSON INJECTOR LUER LOCK N35; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515003
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.
Event or Problem Description
Material#: 515003 lot#: unknown it was reported by the customer that the experienced issues with bd phaseal injectors leaking from the line or when disconnected from the tubing.Verbatim: the customer experienced issues with bd phaseal injectors leaking from the line or when disconnected from the tubing.Additional information: there were no interventions required due to the incident and no visible damage to the product.Unfortunately we do not have the lot #s and the physical products were discarded due to its contact with hazardous drugs.
Additional Manufacturer Narrative
Following the submission of the initial mdr, it was noted that the batch number was unknown and not the number that was reported.Additionally, the batch creation date and batch expiration dates are unknown.Section d: batch updated.
Additional Manufacturer Narrative
Pr 9822199 follow up mdr for device evaluation: a total of eleven samples were provided to our quality team for investigation.The products were visually inspected, no damage or other defects were observed within any of the luer threading.Dimensional testing was performed, including the luer thread, verifying all critical dimensions are within specification.A device history review was performed for suspected lots 2309005 and 2308005, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Product undergoes a series of visual and functional evaluations throughout the manufacturing process.Records were reviewed for the suspected lots and no issues related to this incident were identified.Based on the available information we are not able to identify a root cause related to the manufacturing process 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 LUER LOCK N35
• 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 IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18940855
• Report Number: 3003152976-2024-00173
• Device Sequence Number: 2867649
• Product Code: ONB
• UDI-Device Identifier: 00382905150036
• UDI-Public: (01)00382905150036
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 08/28/2024

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 Expiration Date: 02/28/2026
• Device Catalogue Number: 515003
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 03/05/2024; 08/28/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 04/17/2024; 08/29/2024
• 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