MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MP5304-C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd extension set was separated the following information was received by the initial reporter with the following verbatim: we had an incident where a bd maxplus¿ extension set detached from the with needleless connector while chemotherapy was infusing.Date of incident: (b)(6) 2024 at 1030h patient had iv cisplatin infusing when he called the nurse to inform that the extension set tubing had disconnected from the clear, needleless connector.The iv administration set was still attached to the clear, needleless connector, however the clear needleless connector was no longer attached to the extension set there was a chemotherapy spill as a result of the disconnection between the clear, needleless connector and the extension set tubing this was the 3rd daily administration of iv cisplatin given through the extension set with clear, needleless connector no harm to patient or staff have been reported at this time.
Additional Manufacturer Narrative
Investigation results: it was reported that the maxplus disconnected from the extension set.One sample model mp5304-c was returned for investigation.The set was examined for defects and abnormalities.The maxplus was not returned for investigation.No other defects or abnormalities were observed.A maxplus was connected to the set.The set was attached to a bd primary set and an infusion run was performed at a rate of 125 ml/hr for one hour, the set did not disconnect.An air under water test was performed at approximately 10 psi.The maxzero did not disconnect from the set.The customer complaint was unable to be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review could not be performed because a lot number was not provided by the customer.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: BD EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20169543
• Report Number: 9616066-2024-01264
• Device Sequence Number: 15204310
• Product Code: FPA
• UDI-Device Identifier: 10885403236662
• UDI-Public: (01)10885403236662
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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: Other
• Device Catalogue Number: MP5304-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown