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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC INTRAVASCULAR CATHETER

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BD (SUZHOU) PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383746
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Inflammation (1932)
Event Date 08/14/2020
Event Type  Injury  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that the patient developed an allergic reaction during use with the pegasus pnk 20gax1. 16in prn-capy non-pvc catheter. This complaint was created to capture the 2nd of 2 related incidents. The following information was provided by the initial reporter, translated from (b)(6) to english: "after the puncture by the nurse, the patient showed allergic phenomenon of honeycomb macula on the forearm of one hand, and immediately pulled out the indwelling needle and showed allergic phenomenon after the puncture on the back of the other hand. The second patient showed allergic phenomenon in the eyes and face after the puncture. On (b)(6) 2020, based on the confirmation of the local associate, two patient were affected, detail patient information is unknown. ".
 
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Brand NamePEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC
Type of DeviceINTRAVASCULAR 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
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key10744401
MDR Text Key213388071
Report Number3006948883-2020-00622
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 foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number383746
Device Lot Number9316664
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/12/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/27/2020 Patient Sequence Number: 1
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