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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU PEGASUS YEL 24GAX0.75IN PRN-CAPY NON-PVC CATHETER

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BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU PEGASUS YEL 24GAX0.75IN PRN-CAPY NON-PVC CATHETER Back to Search Results
Catalog Number 383716
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/30/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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 that pegasus yel 24gax0. 75in prn-capy non-pvc had connection issues and leaked. The following information was provided by the initial reporter: the patient was operated on (b)(6) 2021. The patient was given indwelling needle, the y-type connection site to access the connecta in the operating room. When the patient returned to the ward at 14:00 after surgery, the connecta was pre-removed, but it was found that the connection was too tight and could not be removed, so the connecta was not forcibly removed. During infusion of the patient, leakage were found at the y-type connector site due to broken, and could not be used, so the indwelling needle must be removed and the patient was given a second puncture indwelling needle.
 
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Brand NamePEGASUS YEL 24GAX0.75IN PRN-CAPY NON-PVC
Type of DeviceCATHETER
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12724947
MDR Text Key282500020
Report Number3014704491-2021-00234
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
PENDING
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 10/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383716
Device Lot Number1050699
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/19/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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