MAUDE Adverse Event Report: BECTON DICKINSON INFUSION ADAPTER C100-O; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515079
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
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.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
Materials#: unknown (provided by customer is 515979) batch#: unknown.It was reported by the customer that the product is leaking after they attach the product together.Verbatim: rcc received a complaint via phone.The product is leaking after they attach the product together.515064.515056 and 515979.
Event or Problem Description
Material number updated.
Additional Manufacturer Narrative
Follow up mdr for correction.Following the submission of the initial mdr, it was noted that the material number was submitted as unknown.This has been corrected.Section d: material number and medical device brand name updated section g: 510k updated.
Event or Problem Description
Materials#: 515079 batch#: unknown it was reported by the customer that the product is leaking after they attach the product together.Verbatim: rcc received a complaint via phone.Pir attached.The product is leaking after they attach the product together.515064; 515056; 515079.Per follow up with rep: we have been to this clinic and worked with them on proper use of phaseal optima.They were not using it correctly so it is not a product issue.Our team trained the staff on proper usage moving forward.
Additional Manufacturer Narrative
(b)(4).Follow up mdr for additional information/evaluation additional information/evaluation: per sales rep, we have been to this clinic and worked with them on proper use of phaseal optima.They were not using it correctly so it is not a product issue.Our team trained the staff on proper usage moving forward.

• Brand Name: INFUSION ADAPTER C100-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 IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18884748
• Report Number: 3003152976-2024-00153
• Device Sequence Number: 7604948
• Product Code: ONB
• UDI-Device Identifier: 00382905150791
• UDI-Public: (01)00382905150791
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K181221
• 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): 05/22/2024

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 Catalogue Number: 515079
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 05/02/2024; 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown