MAUDE Adverse Event Report: ADD ON KIT W/03 ML SAFESET¿ RESERVOIR AND 2" RED STRIPE PT TUBING; CATHETER, CONTINUOUS FLUSH

Catalog Number 011-46105-77

Device Problem Disconnection (1171)

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

Event Date 04/16/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.Investigation is pending.

Event Description

The event occurred at 3pm and involved a add on kit w/03 ml safeset¿ reservoir and 2" red stripe pt tubing that the customer reported a disconnection distal to the safeset reservoir.The device was in use for 8 hours and no medication was being used with the device.There was patient involvement and a delay in therapy, however, no report of adverse event.This is the second of three events reported.

Manufacturer Narrative

Received one new list# 011-46105-77, add on kit w/03 ml safeset¿ reservoir and 2" red stripe pt tubing.Lot# 4944824, one new list# 011-46105-77, add on kit w/03 ml safeset¿ reservoir and 2" red stripe pt tubing.Lot# 4916116, one empty pouch with list# 011-46105-77, add on kit w/03 ml safeset¿ reservoir and 2" red stripe pt tubing.Lot# 3817662.The reported complaint of product disconnection was not confirmed on the returned sets.No visual anomalies were observed on the returned new sets.The returned sets were primed and pressure leak tested and no leaks were observed.The products had performed per the specifications.Without the return of the reported sample the complaint could not confirmed.A device history review (dhr) lot# 4944824, 4916116 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: ADD ON KIT W/03 ML SAFESET¿ RESERVOIR AND 2" RED STRIPE PT TUBING
• Type of Device: CATHETER, CONTINUOUS FLUSH
• MDR Report Key: 11812721
• MDR Text Key: 250426654
• Report Number: 9617594-2021-00155
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K932188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-46105-77
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/12/2021
• Supplement Dates Manufacturer Received: 05/13/2021
• Supplement Dates FDA Received: 05/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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