MAUDE Adverse Event Report: BECTON DICKINSON PROTECTOR P13-O; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
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 needle which punctures the vial snapped while attempting to attach it to a vial.
Additional Manufacturer Narrative
(b)(4).Follow up mdr for device evaluation: one protector sample was provided to our quality team for investigation.Through visual inspection, the protector spike is twisted and observed to be broken, verifying the reported incident.A device history review was performed for reported lot 2403413, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this incident.The product was visually inspected and no damage or defects were observed.Functional testing was performed, in all cases the protectors were properly fitted to the vial without issue and no damage to the spike occurred.Product is visually and functionally tested throughout manufacturing according to procedure, ensuring the quality and functionality of the device, including verification that all critical dimensions are within specification, no issues related to the reported issue were noted.Based on our investigation we cannot identify a root cause related to our manufacturing process at this time.It is important to ensure the device is properly placed within the assembly fixture.It is likely the spike twisted during the connection of the protector onto the vial.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.
Event or Problem Description
The needle which punctures the vial snapped while attempting to attach it to a vial.They use the assembly fixture.

• Brand Name: PROTECTOR P13-O
• 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: 20630232
• Report Number: 3003152976-2024-00585
• Device Sequence Number: 7929863
• Product Code: ONB
• UDI-Device Identifier: 00382905150609
• UDI-Public: (01)00382905150609(11)240401(17)260228(10)2403413
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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 Expiration Date: 02/28/2026
• Device Catalogue Number: 515060
• Device Lot Number: 2403413
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown