MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEC SET 20DP 30IN W/HANGER LL; INTRAVASCULAR ADMINISTRATION SET

Model Number 72213N

Device Problems Leak/Splash (1354); Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that a sec set 20dp 30in w/hanger ll was missing a component and missing the end cap before use.The following was reported by the initial reporter: "it was reported that the iv tubing set was incomplete and missing the end piece.Verbatim: i was onsite at xxx (b)(6) hospital- same day surgery- yesterday for some piv follow-up.While i was there, xxx (team lead) had approached me about issues with the carefusion iv tubing that they use for surgery.She had two incidences of faulty iv tubing.Both sets were incomplete, without the end piece attached.She does still have those faulty sets and the packages they came in.I wasn¿t sure if you wanted to get in contact with her? right now xxx health is not allowing outside emails to be sent so xxx gave me her personal email.".

Manufacturer Narrative

H.6.Investigation: no product or photo was returned by the customer.The customer complaint of misassembly could not be verified due to the product not being returned for failure investigation.A device history record review for model 72213n lot number 20073310 was performed.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.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of misassembly with lot #20073310 regarding item #72213n.

Event Description

It was reported that a sec set 20dp 30in w/hanger ll was missing a component and missing the end cap before use.The following was reported by the initial reporter: "it was reported that the iv tubing set was incomplete and missing the end piece.Verbatim:.I was onsite at xxx general hospital- same day surgery- yesterday for some piv follow-up.While i was there, xxx (team lead) had approached me about issues with the carefusion iv tubing that they use for surgery.She had two incidences of faulty iv tubing.Both sets were incomplete, without the end piece attached.She does still have those faulty sets and the packages they came in.I wasn¿t sure if you wanted to get in contact with her? right now xxx health is not allowing outside emails to be sent so xxx gave me her personal email.".

• Brand Name: SEC SET 20DP 30IN W/HANGER LL
• 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 22244 ; MX 22244
• MDR Report Key: 11033665
• MDR Text Key: 250326642
• Report Number: 9616066-2020-20611
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203010086
• UDI-Public: 37613203010086
• Combination Product (y/n): N
• PMA/PMN Number: K790582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2023
• Device Model Number: 72213N
• Device Catalogue Number: 72213N
• Device Lot Number: 20073310
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1