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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVENOUS CATHETER

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BD (SUZHOU) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVENOUS CATHETER Back to Search Results
Catalog Number 383914
Device Problem Fail-Safe Design Failure (1222)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/18/2017
Event Type  malfunction  
Manufacturer Narrative
Customer stated that the shield activation failed when the needle was withdrawn from the patient. A sample was provided by the customer and investigated by the quality engineer. It was found that the v-clip was deformed and would not assemble with the catheter adapter successfully. Current assembly process from the pegasus auto line only checks the presence before assembling which we found the washer can pop out at the low probability. The production record was reviewed and no non-conformance was noted during the manufacturing of this lot related to complaint issue. Conclusion: the root cause for this incident was determined to be a deformed v-clip.
 
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. (b)(4).
 
Event Description
It was reported during use of the bd pegasus¿ safety closed iv catheter system the nurse successfully advanced the catheter, however when the nurse withdrew the needle the shield activation failed. There was no report of injury or medical intervention.
 
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Brand NameBD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
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 Key6942219
MDR Text Key251199350
Report Number3006948883-2017-00076
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 10/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Catalogue Number383914
Device Lot Number7095216
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 Received09/18/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/05/2017
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: 10/11/2017 Patient Sequence Number: 1
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