MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS YEL 24GA X 0.75IN PRN; INTRAVASCULAR CATHETER

Catalog Number 383911

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 11/29/2022

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 was reported while using bd pegasus yel 24ga x 0.75in prn the needle could not be disengaged.There was no report of patient impact.The puncture was successful when the indwelling needle was injected, the blood returned.When the needle core was ready to be pulled out, it was found that it could not be pulled out.After several unsuccessful attempts, he had to pull it out and start again.

Manufacturer Narrative

H6: investigation summary a device history review was conducted for lot number 2140902.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.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.H3 other text : see h10.

Event Description

It was reported while using bd pegasus yel 24ga x 0.75in prn the needle could not be disengaged.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: the puncture was successful when the indwelling needle was injected, the blood returned.When the needle core was ready to be pulled out, it was found that it could not be pulled out.After several unsuccessful attempts, he had to pull it out and start again.

• Brand Name: BD PEGASUS YEL 24GA X 0.75IN PRN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16007140
• MDR Text Key: 308237328
• Report Number: 3014704491-2022-00680
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383911
• Device Lot Number: 2140902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2022
• 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