MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MPX5300-C
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4.Medical device lot # 23129264.D4.Medical device lot # 24029513.D4.Medical device lot # 24019360.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 maxplus pressure rated extension set with needleless connector and y-site detached the following information was received by the initial reporter with the following verbatim: it was reported by customer that spriros falls from maxplus injections site.
Event or Problem Description
Material#: mpx 5300-c, batch#: 23129264, 24029513, 24019360.It was reported by customer that spriros falls from maxplus injections site on mpx5300-c.Bd rep met with customer on (b)(6).There have been 3 instances the nursing team can recall: the video attached is from on (b)(6) incident which was yesterday.Lot number possible for extension mpx 5300-c, 23129264, 24029513, 24019360 in the other 2 instances the nurses were able to administer the doxorubicin (which was re-prepared by pharmacy), at the same port on the extension clave.Due to this reason, we are also reporting this to the icu medical team as it can possibly be the spiros clave (not sure the batch) these instances occurred in the oncology clinic, and there were no instances reported on any in-pt units.Spriros falls from maxplus injections site on mpx5300-c.
Additional Manufacturer Narrative
It was reported by customer that spriros falls from maxplus injections site on mpx5300-c.A video was submitted of a maxplus connector for quality evaluation.Evaluation of the video shows that the maxplus connector disconnects when connected to a corresponding connector.The customer complaint of connection issues was confirmed.A root cause analysis could not be conducted because a physical sample was not provided.A device history record review for model: mkpx5300-c, lot number: 23129264 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 18dec2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model: mkpx5300-c, lot number: 24029513 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 29feb2024.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model mkpx5300-c, lot number: 24019360 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 23jan2024.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE
• 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: 20141671
• Report Number: 9616066-2024-01250
• Device Sequence Number: 3226433
• Product Code: FPA
• UDI-Device Identifier: 10885403237218
• UDI-Public: (01)10885403237218
• 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): 01/15/2025

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: Other
• Device Catalogue Number: MPX5300-C
• Device Lot Number: SEE H.10
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 01/15/2025
• 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