MAUDE Adverse Event Report: GEM 20DP CKV 3SS DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Model Number 2426-0007

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.Initial reporter facility name: (b)(6) campus.Device manufacture date: unknown.Investigation summary: a complaint of tubing being cracked and leaking 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 on model 2426-0007 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.Investigation conclusion: due to no sample being received, an investigation could not be performed and a root cause could not be determined.No product will be returned per customer.No investigation was performed.

Event Description

It was reported that the gem 20dp ckv 3ss dehp free experienced device damage while still considered operable.The following information was provided by the initial reporter: we would like to report alaris tubing that is cracking during chemo therapy infusion.We had a chemo spill.

Event Description

It was reported that the gem 20dp ckv 3ss dehp free experienced device damage while still considered operable.The following information was provided by the initial reporter: we would like to report alaris tubing that is cracking during chemo therapy infusion.We had a chemo spill.

Manufacturer Narrative

H6: investigation summary a complaint of tubing being cracked and leaking 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 on model 2426-0007 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.

• Brand Name: GEM 20DP CKV 3SS DEHP FREE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12470311
• MDR Text Key: 271375640
• Report Number: 9616066-2021-52038
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403227996
• UDI-Public: 50885403227996
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2021
• 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