MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM WITH Q-SYTE¿; INTRAVASCULAR CATHETER

Catalog Number 383717

Device Problems Leak/Splash (1354); Defective Component (2292)

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

Event Date 12/12/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the q-syte of the bd pegasus¿ safety closed iv catheter system with q-syte¿ was damaged and leaked during use.The following information was provided by the initial reporter, translated from chinese: "the nurses used pegasus to patients, and the q-syte connector was damaged and leaked.".

Event Description

It was reported that the q-syte of the bd pegasus¿ safety closed iv catheter system with q-syte¿ was damaged and leaked during use.The following information was provided by the initial reporter, translated from chinese: "the nurses used pegasus to patients, and the q-syte connector was damaged and leaked.".

Manufacturer Narrative

The following fields were updated due to additional information: d4: medical device lot #: 2228258; d4: medical device expiration date: 23-aug-2025; h4: device manufacture date: 16-aug-2022.D10: device available for eval yes, d10: returned to manufacturer on: 10-feb-2023.H6: investigation summary a sample has been provided to aid in our investigation.During visual analysis of the device, our engineers observed that the septum of the qsyte did not have the slit required to allow for fluid passage.This nonconformance has been confirmed.The root cause for a missing septum is most likely related to the setup of the manufacturing line.Current inspections protocols require evaluating all devices for the presence of a slit in the septum.Nonconforming materials are segregated and destroyed.A device history review was conducted for lot number 2228258.Retain sample testing was performed 45psi system leak testing for retain sample, no abnormality found.H3 other text : see h10.

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM WITH Q-SYTE¿
• 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: 16080668
• MDR Text Key: 308243195
• Report Number: 3014704491-2022-00717
• 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: 02/21/2023

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: Health Professional
• Device Catalogue Number: 383717
• Device Lot Number: 2228258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2022
• 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