MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEC SET NO PORTS W/HANGER DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Model Number 11448964

Device Problems Device Contamination with Chemical or Other Material (2944); No Flow (2991)

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

Event Date 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: a complaint of the drip chamber breaking from the set was received from the customer.A photo was provided to aid in the investigation of this defect.In the photo, separation of the drip chamber can be seen.The customer complaint was confirmed.A device history record review could not be performed on model 11448964 because a lot number was not provided by the customer.As the sample was not returned a definitive root cause could not be established.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 Description

It was reported that the sec set no ports w/hanger dehp free tubing broke below the drip chamber before flushing out the cytotoxic chemotherapy medicine.The following information was provided by the initial reporter: "rn was clamping roller clamp before flushing cytotoxic chemotherapy and the tubing broke right below the drip chamber.This is a safety hazard to staff and patients in the context of hazardous drug administration.".

• Brand Name: SEC SET NO PORTS W/HANGER DEHP FREE
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12259600
• MDR Text Key: 264517923
• Report Number: 9616066-2021-51676
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403234741
• UDI-Public: 50885403234741
• 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,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11448964
• Device Catalogue Number: 11448964
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1