MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 60/9 PCC

Lot Number 5238461

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that the infusion set's tubing came off at the quick release site, sometime during work.Reportedly, it did not get severed or pulled, but the patient noticed that the tube was dangling.The site location was on the left side of the abdomen and the pump was in the patient's t-shirt pocket.Moreover, the infusion had been in use for one day.The infusions were stored in the cabinet.There was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.Upon investigation performed on the returned used device (2 tubing), it was found that the tubing was detached from the tubing connector.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Type of Device: QUICK-SET 60/9 PCC
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 9514781
• MDR Text Key: 183105206
• Report Number: 3003442380-2019-01992
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006416
• UDI-Public: 05705244006416
• Combination Product (y/n): N
• PMA/PMN Number: K160648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial

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: No Information
• Device Expiration Date: 08/01/2021
• Device Lot Number: 5238461
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 12/24/2019
• Type of Device Usage: N
• Patient Sequence Number: 1