MAUDE Adverse Event Report: BECTON DICKINSON UNKNOWN PHASEAL; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	UNKNOWN
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Follow up mdr for device evaluation.As no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a root cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information.
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.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
Material# unknown batch# unknown it was reported by customer that the injector may not remove the connector and will not disengage when the connection is broken.The medication will continue to flow, which is contrary to the mechanism of the product and to the reason for using the product.Verbatim rcc received a complaint via email.Email(s) attached.Patient was connected to home infusion pump.A safety device is used to keep male/female connector and injector from coming apart, however it does not connect to the power port tubing, nor does it cover the max clear connector at the end of each power port needle catheter.In fact, the turtleneck actually keeps the two safety products "married" and opens the flow, therefore the injector may not remove the connector and will not disengage when the connection is broken.The medication will continue to flow, which is contrary to the mechanism of the product and to the reason for using the product.In this case, 5fu was being infused.A patient may be disconnected from the cadd without the pump "knowing" thus causing it to continue running out onto the patient.The patient entered the area to be disconnected from her home infusion pump (cadd).Upon arrival the nurse noticed that the max clear was covered with a white film, which is consistent with chemo (5fu) spillage.The nurse disconnected the patient.A portion of the connection was loose and slightly wet at the hub where connection takes place.The patient stated, "it came off on the way here and i put it back"(which was probably difficult for a lay person to do as one must press inward, hold together and screw it all at once).She stated it had happened recently and had not been that way all night.One could assume since the bag was empty (full volume infused) that if it happened as she described, she received what is considered a full dose.There was a great potential for harm if the patient had not noticed the disconnection immediately.The medication was disconnected per protocol and no exposure to the drug was witnessed by the nurse.

• Brand Name: UNKNOWN PHASEAL
• 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: 19700251
• Report Number: 3003152976-2024-00398
• Device Sequence Number: 15397673
• Product Code: ONB
• UDI-Device Identifier: 00382905150852
• UDI-Public: (01)00382905150852
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 07/09/2024
• 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