• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383914
Device Problems Fluid/Blood Leak (1250); Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/28/2022
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 6 bd pegasus¿ safety closed iv catheter systems' had damaged tubing and liquid leaked from them during use.The following information was provided by the initial reporter, translated from (b)(6) : "the head nurse found the leakage from the catheter tube when using the product" "there is liquid leakage at the catheter tubing, the catheter tubing was damaged, there was no catheter tubing breakage, and the abnormal product has been returned.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 18-apr-2022 h.6.Investigation: a device history review was conducted for lot number 1229796.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 several samples were submitted to aid in our investigation.Our engineers were able to identify damage along catheter tubing that is consistent with a needle puncture.Needle punctures that are generated during the manufacturing process will lead to an inoperable device.It is possible that during use the device maybe partially retracted by the operator which can lead to puncture of and leakage through the catheter tubing.Based on the available observation our engineers were unable to associate this failure mode with the manufacturing process.H3 other text : see h.10.
 
Event Description
It was reported that 6 bd pegasus¿ safety closed iv catheter systems' had damaged tubing and liquid leaked from them during use.The following information was provided by the initial reporter, translated from chinese: "the head nurse found the leakage from the catheter tube when using the product" "there is liquid leakage at the catheter tubing, the catheter tubing was damaged, there was no catheter tubing breakage, and the abnormal product has been returned.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
no.1 liangpu street
suzhou industrial park
suzhou 21512 6
CH  215126
Manufacturer (Section G)
BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
no.1 liangpu street
suzhou industrial park
suzhou 21512 6
CH   215126
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14148257
MDR Text Key290157197
Report Number3014704491-2022-00150
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
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 05/25/2022
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 Number383914
Device Lot Number1229796
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/28/2022
Initial Date FDA Received04/19/2022
Supplement Dates Manufacturer Received05/25/2022
Supplement Dates FDA Received06/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-