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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
The following was reported via email:please find attached a second quality defect report concerning: bd phaseal injector luer lock ref : 515003 lot: 2404004 the entire batch presumed to be defective as well as the injector concerned by this new incident are kept at the pui, since this is the second incident reported on this batch, would a refund or exchange be possible? the quantity concerned is 8 injectors.Circumstances / description: as she withdraws from the phaseal system protector, the stitcher sees the injector canula stuck in the septum.After disengagement with difficulty, the canula remains outside.Conservation measures and actions taken : the injector was kept at the pui manufacturer and injector declaration available for analysis.Whole lot kept (8 injectors) request exchange or refund.
Additional Manufacturer Narrative
(b)(4).Follow up mdr for device evaluation: one injector sample was provided to our quality team for investigation.Upon visual inspection, the grips of the safety sleeve are observed to be bent causing the needle to be exposed.A device history review was performed for reported lot 2404004, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this incident.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification all critical dimensions are within specification and there is no damage on the product.Testing results were reviewed for the reported lot and found all product met required specifications.It is important to grip the white injector components when engaging/ disengaging; do not grip the blue safety sleeve.If the safety sleeve grips become dislocated, the injector is activated causing needle exposure.To prevent damage to the handles of the safety sleeve, the injector must be removed by pulling it backwards and must not be forcefully engaged.The instructions for use must be carefully followed when using phaseal devices in order to avoid any damage to the product that may result in the device not functioning as intended.Based on the available information, we are unable to identify a root cause related to the manufacturing process at this time.It appears that this incident was due to excessive force during connection/disconnection of the device.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.

• 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
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20180669
• Report Number: 3003152976-2024-00503
• Device Sequence Number: 15629348
• Product Code: ONB
• UDI-Device Identifier: 00382905150036
• UDI-Public: (01)00382905150036(11)240426(17)260930(10)2404004
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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: 09/30/2026
• Device Catalogue Number: 515003
• Device Lot Number: 2404004
• 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: 09/06/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown