MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD 9 IN EXTENSION SET W/MAX Y; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MPX5300-C
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd 9 in extension set w/max y disconnected.The following information was provided by the initial reporter: "the tubing was found to be disconnected upon the nurse entering the room.At the time the iv was running an infusion of sedation medication at the time of failure.".
Event or Problem Description
It was reported that the bd 9 in extension set w/max y disconnected.The following information was provided by the initial reporter: "the tubing was found to be disconnected upon the nurse entering the room.At the time the iv was running an infusion of sedation medication at the time of failure." the customer does still have the contaminated device in her possession.Please mail proper packaging to the attention below and she will mail it back for investigation.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 26-oct-2022.H.6.Investigation summary: one sample and one photo was submitted for quality investigation.The customer complaint of separation was verified by sample investigation.Evaluation of the photo submitted indicates that the tubing of the extension set separated at the tubing inlet side of the smartsite y-site body.Additionally, examination of the sample submitted was conducted.The tubing of that should have been connected to the assembly was not submitted, however, it is clear that the there are no pieces of the tubing remaining at the inlet of the y-site, and therefore we can say that the tubing had separated from the assembly and was not pulled or cut away.A device history record review could not be performed because the lot number is unknown.The root cause of the failure seen in the sample is the solvent at the union was not given the correct amount of time to set and create a complete bond.Under magnification it can bee seen that the solvent residue on the y-site body is minimal and would allow for separation of the tubing to occur easily.The manufacturing location was made aware and it was determined that the most likely reason for the issue is not following the correct assembly procedure due to personnel.Updates to the assembly process have been made to correct the issue.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD 9 IN EXTENSION SET W/MAX Y
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15700960
• Report Number: 9616066-2022-01660
• Device Sequence Number: 8193014
• Product Code: FPA
• UDI-Device Identifier: 10885403237218
• UDI-Public: 10885403237218
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown