MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM 20DP MC .2MF 2SS DEHP-FREE; INTRAVASCULAR ADMINISTRATION SET

Model Number 10015012

Device Problem Break (1069)

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

Event Date 07/06/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(6).Initial reporter zip: (b)(6).Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: a complaint of a set having tiny holes in the tubing was received from the customer.No product or photo was returned by the customer.The customer complaint of component damage could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a lot number was not provided by the customer.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.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported gem 20dp mc.2mf 2ss dehp-free was damaged causing the tubing to rupture.The following information was provided by the initial reporter: "at time of hook-up, writer was putting lines into iv pump and noticed tpn line was wet.With closer examination at lines, multiple tiny holes were on the flexible part of the tpn tubing that goes into pump and tpn was spraying out everywhere.This only occurred to the tpn line (buretrol with filter).Pt had not yet been accessed when this all occurred.".

• Brand Name: GEM 20DP MC .2MF 2SS 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
• MDR Report Key: 12464167
• MDR Text Key: 271306096
• Report Number: 9616066-2021-52021
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403233959
• UDI-Public: 50885403233959
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 10015012
• Device Catalogue Number: 10015012
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2021
• 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