MAUDE Adverse Event Report: PEGASUS PNK 20GA X 1.16IN QSYTE NON-PVC; INTRAVASCULAR CATHETER

Catalog Number 383747

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/09/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the pegasus pnk 20ga x 1.16in qsyte non-pvc leaked pumeixien onto the patient during the high-pressure injection.The following information was provided by the initial reporter, translated from (b)(6) to english: "the client injected "pumeixien" with high pressure in the process of use, and the drug spilled and splashed over the patient's whole body.The technician suspected leakage at the junction, and the patient's vascular condition was poor and the cost of contrast agent was high." "the patient was in good condition and was not injured.After the contrast agent was ejected, the customer quickly consoled the patient, pulled out the indwelling needle and re-catheterized the patient".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval?: yes.D10: returned to manufacturer on: 7/18/2021.H6: investigation: a device history review was conducted for lot number 0337383.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, the returned sample has been subjected to leakage testing.The results of these tests were unable to detect any leakage of the device under normal use.

Event Description

It was reported that the pegasus pnk 20ga x 1.16in qsyte non-pvc leaked pumeixien onto the patient during the high-pressure injection.The following information was provided by the initial reporter, translated from chinese to english: "the client injected "pumeixien" with high pressure in the process of use, and the drug spilled and splashed over the patient's whole body.The technician suspected leakage at the junction, and the patient's vascular condition was poor and the cost of contrast agent was high." "the patient was in good condition and was not injured.After the contrast agent was ejected, the customer quickly consoled the patient, pulled out the indwelling needle and re-catheterized the patient".

• Brand Name: PEGASUS PNK 20GA X 1.16IN QSYTE NON-PVC
• Type of Device: INTRAVASCULAR CATHETER
• MDR Report Key: 12298480
• MDR Text Key: 265829252
• Report Number: 3014704491-2021-00071
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/24/2023
• Device Catalogue Number: 383747
• Device Lot Number: 0337383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2021
• Date Manufacturer Received: 09/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2020
• 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