MAUDE Adverse Event Report: BECTON DICKINSON INJECTOR LOCKING N40-O MULTI; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515057
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Mat#: 515057; batch#: unknown.It was reported that the phaseal optima injector came off the line at the end of treatment.They attach the phaseal to the line when they prime them.They sit in the fridge for up to 9 days.Also, they are able to get them off the lines.This is not the fault of the phaseal, but the line.If pull back the collar, it can get the phaseal off.Verbatim: the phaseal optima injector came off the line at the end of treatment.We attach the phaseal to the line when we prime them.They sit in the fridge for up to 9 days.This would not affect anything, right? also, we are able to get them off the lines.This is not the fault of the phaseal, but the line.If you pull back the collar, you can get the phaseal off.
Additional Manufacturer Narrative
(b)(4).Initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Device problem code: a1205: loose or intermittent connection (1371).Patient problem code: f26: no health consequences or impact.

• Brand Name: INJECTOR LOCKING N40-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): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 17896364
• Report Number: 3003152976-2023-00443
• Device Sequence Number: 17001577
• Product Code: ONB
• UDI-Device Identifier: 00382905150579
• UDI-Public: (01)00382905150579
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K201099
• 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
• Report Date (Section B): 10/04/2023

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: 515057
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown