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

Catalog Number 10016073

Device Problems Leak/Splash (1354); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2023

Event Type  malfunction  

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd alaris secondary set separated.The following information was received by the initial reporter with the verbatim: experienced a failure involving a different lot number where the secondary set tubing is detaching from the base of the drip chamber.The event occurred on october 24th at the yarmouth regional hospital.The drug involved was pembrolizumab and that customer expects that the set was discarded and replacement of this medication was necessitated.

Event Description

No additional information.

Manufacturer Narrative

Investigation results: no product or photo was returned by the customer.The customer complaint of separation other component - leak could not be verified due to the product not being returned for failure investigation.A device history record review for material# 10016073 and lot# 23039322 was performed.The search showed that a total of (b)(6) units in 1 lot number was built on 31mar2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.

• Brand Name: BD ALARIS SECONDARY SET
• Type of Device: 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: 18136993
• MDR Text Key: 329255440
• Report Number: 9616066-2023-02199
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403230118
• UDI-Public: (01)50885403230118
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K790582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 10016073
• Device Lot Number: 23039322
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Male