MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. PEGASUS BL 22GAX1.00IN QSYTE-CAPY NONPVC INTRAVASCULAR CATHETER

Catalog Number 383738

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 09/02/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.

Event Description

It has been reported that one pegasus bl 22gax1. 00in qsyte-capy nonpvc has been found experiencing leakage during use. The following has been provided by the initial reporter: it's noticed that leakage at q-syte (not the diaphragm on the q-syte,not the screw, leakage at conjunction site) and then the infusion set is closed. At this time, the blood is returned to the joint. The patient's blood leaked from the leak. Leaked blood confirmed to be a little. No adverse reaction on patient.

• Brand Name: PEGASUS BL 22GAX1.00IN QSYTE-CAPY NONPVC
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• Manufacturer (Section G): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9082937
• MDR Text Key: 178791559
• Report Number: 3006948883-2019-00776
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PENDING
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/02/2022
• Device Catalogue Number: 383738
• Device Lot Number: 9023769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/18/2019 Patient Sequence Number: 1