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

Catalog Number	515306
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
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: product details ¿ product name: phaseal infusion adapter (c100) ¿ material/catalogue number: 515306 ¿ lot number(s): 2411207 ¿ date of incident: (b)(6) 2025 ¿ description of event (please provide specific details of the issue you experienced): during packing, the septum on the c100 popped out, causing a spill inside the clear plastic bag.We do not use or tamper with the side port.The hole left by the popped septum resulted in excessive leakage.¿ sample availability: no.¿ if the event involved any of the following, please include provide additional detail: - death/serious injury - no.- erroneous results - no.- exposure to blood/bodily fluids - no.- safety issue - had the product not been bagged in a clear plastic bag, it could have resulted in a significant leak, potentially affecting a staff member or patient.- medical interventions required - no.¿ pictures/videos (if possible) clearly showing the incident/defect - attached.
Additional Manufacturer Narrative
(b)(4).Follow up mdr for device evaluation: three photos and a video was provided to our quality team for investigation.Through visual evaluation, it was observed that the membrane was disconnected, verifying the reported incident.A device history review was performed for lot 2411207; no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Three retained samples were used for additional evaluation.All product was visually inspected and verified the membranes were properly assembled.A detection system is used to verify the proper welding and location of the membrane.All quality records verify the inspections were performed according to procedure.While we cannot identify a direct issue, it was determined this incident is due to improper welding of the membrane and the detection system also not identifying/rejecting the impacted piece.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 tracked and trended for future occurrence.
Event or Problem Description
No additional information.

• Brand Name: INFUSION ADAPTER C100
• 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: 21915964
• Report Number: 3003152976-2025-00159
• Device Sequence Number: 18348431
• Product Code: ONB
• UDI-Device Identifier: 00382905153068
• UDI-Public: (01)00382905153068(11)241118(17)281031(10)2411207
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123213
• 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): 05/21/2025

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 Catalogue Number: 515306
• Device Lot Number: 2411207
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 04/27/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown