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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) PEGASUS PNK 20GA X 1.16IN QSYTE-CAP INTRAVENOUS CATHETER

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BD (SUZHOU) PEGASUS PNK 20GA X 1.16IN QSYTE-CAP INTRAVENOUS CATHETER Back to Search Results
Catalog Number 383944
Device Problems Device Operates Differently Than Expected (2913); Fail-Safe Problem (2936)
Patient Problem Needle Stick/Puncture (2462)
Event Date 10/10/2017
Event Type  malfunction  
Manufacturer Narrative
Sample was returned and decontaminated. Returned sample showed the tip shield are separated with cannula. The exposed cannula v-clip didn't activate. There is a missing washer, which resulted in the cannula being exposed. There is a missing washer, which caused the cannula to be directly exposed to the customer. The washer is manually assembled, the operator will conduct a visual inspection. Root cause: the root cause is the missing washer which caused the cannula to be exposed. Manufacturing inspection: after reviewing dhr, no abnormality was found in in-coming inspection, whole assembly process and qa inspection. Bd was able to confirm the customer's indicated failure mode.
 
Manufacturer Narrative
Initial reporter phone#: (b)(6). Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us. 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 during use of the pegasus pnk 20ga x 1. 16in qsyte-cap nurse found safety shield activation failed when withdrawing needle. The nurse received needle stick. There was no report of injury or medical intervention.
 
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Brand NamePEGASUS PNK 20GA X 1.16IN QSYTE-CAP
Type of DeviceINTRAVENOUS 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
8015652845
MDR Report Key6999822
MDR Text Key252914219
Report Number3006948883-2017-00084
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/30/2018
Device Catalogue Number383944
Device Lot Number5296195
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/23/2015
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: 11/03/2017 Patient Sequence Number: 1
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