MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. PEGASUS YEL 24GA X 0.75IN QSYTE NON-PVC; CATHETER

Catalog Number 383717

Device Problems Break (1069); Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem Blood Loss (2597)

Event Date 01/09/2020

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 yel 24ga x 0.75in qsyte non-pvc has been found damaged and with the needle breaking during use.The following has been provided by the initial reporter: when the nurse inserted the needle, a broken part appeared at the extension tube near the isolation plug, there were traces of scotch tape.The broken needle did not remain in the patient's body.During use, the clinical nurse completed the puncture for the patient.After withdrawing the needle core, he found that the amount of blood returned was large.He then withdrew the indwelling needle and found that the needle tube and extension tube were broken.Broken needles have been treated.Photos of broken extension tubes, isolation plugs, and defects can be returned to the suzhou factory for investigation.This event caused a large amount of blood leakage in the patient, and the amount of blood leakage could not be confirmed.

Event Description

It has been reported that one pegasus yel 24ga x 0.75in qsyte non-pvc has been found damaged and with the needle breaking during use.The following has been provided by the initial reporter: when the nurse inserted the needle, a broken part appeared at the extension tube near the isolation plug, there were traces of scotch tape.The broken needle did not remain in the patient's body during use, the clinical nurse completed the puncture for the patient.After withdrawing the needle core, he found that the amount of blood returned was large.He then withdrew the indwelling needle and found that the needle tube and extension tube were broken.Broken needles have been treated.Photos of broken extension tubes, isolation plugs, and defects can be returned to the suzhou factory for investigation.This event caused a large amount of blood leakage in the patient, and the amount of blood leakage could not be confirmed.

Manufacturer Narrative

H.6 investigation summary: a device history review was conducted for lot number 9141607.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.After evaluating the returned device our quality engineers have determined that the root cause for the tubing leakage is human error, our engineers were unfortunately unable to evaluate the needle identified in the report as the needle was not returned.During the production process roles of tubing are bound together using a red plastic, which was also present on the used device.The color is chosen as a signal to inspection staff who are responsible for segregating the material.To address this issue, we have notified our inspection staff of this occurrence and issued a retraining of our team.

• Brand Name: PEGASUS YEL 24GA X 0.75IN QSYTE NON-PVC
• Type of Device: CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• MDR Report Key: 9643996
• MDR Text Key: 181545153
• Report Number: 3006948883-2020-00037
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: PENDING
• 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: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2022
• Device Catalogue Number: 383717
• Device Lot Number: 9141607
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other