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

Catalog Number	515078
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
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
Material # 515078.Batch # 2404502.Verbatim: rcc received a complaint via email.Blue piece came detached causing chemo spill.We had an rn in our xxx call today to report they just had a chemo spill caused by the c100 bag spike coming completely out of the bag.We thought it strange as the spike is pushed firmly into the port end however when the product (which happened to be a very expensive medication) was remade and brought up to the unit the rn explained to the technician what had happened.She popped the bottom end of the line access cover on the bottom of the c100 spike and the whole blue rubber part of the c100 phaseal came off from the white hard plastic piece.I attempted to pull down on the blue rubber part of a new c100 and with some trying, it did come apart.I don't know if they had a faulty c100 or if some other thing happened.We wanted to put this out there in case there are others who experience an issue.The batch this was from is lot 2404502.Product code: 2404502.Customer response on december 23, 2024.1.Can you please provide an exact date of event in format mm-dd-yyyy? 12-17-2024.2.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Rn replied no patient harm only a delay in treatment due to spill clean up and remix of product.3.Any sample available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? no sample available, disposed of with spill.4.Could you please confirm which medication was being administered and leaked? dinutuximab.
Additional Manufacturer Narrative
Pr (b)(4) follow up mdr for device evaluation: three photos were provided to our quality team for investigation.Through visual inspection, the body of the infusion adapter was observed to be disconnected from the blue port, verifying the reported incident.A device history review was performed for lot 2404502, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this incident.Product undergoes a series of inspections throughout the manufacturing process to ensure the quality and functionality of the device, including force testing to verify the connection of these components.Results were reviewed for the reported lot and verified to be within specified limits.Three retained samples of the reported lot were used for additional evaluation.All product was inspected, no damage or other defects were observed.Force testing was completed on the retained products and confirmed limits met required specification.While we cannot identify a direct issue, it was determined this incident occurred during the assembly process.To date, there have been no other similar events reported for this lot.Complaints received for this device and reported condition will continue to be monitored by our quality team for signs of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: INFUSION ADAPTER C100-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): 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: 21035990
• Report Number: 3003152976-2024-00674
• Device Sequence Number: 12655774
• Product Code: ONB
• UDI-Device Identifier: 00382905150784
• UDI-Public: (01)00382905150784(11)240412(17)260331(10)2404502
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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: 03/31/2026
• Device Catalogue Number: 515078
• Device Lot Number: 2404502
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown