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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 20G X 1.16 IN. INTRAVASCULAR CATHETER

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BD (SUZHOU) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM 20G X 1.16 IN. INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383742
Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/31/2017
Event Type  Injury  
Manufacturer Narrative
(b)(6). Results: one used samples was returned for evaluation. A visual inspection revealed the returned unit was a section of a broken catheter. No unit package or other parts of the device were returned. A microscopic inspection revealed that the returned catheter was 25 mm long and the cross section and profile were uneven and irregular with signs of pulling and shrinkage. The internal and outer diameter of the catheter was measured and no abnormalities were observed. A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6111459. A manufacturing review revealed no abnormalities with incoming material, assembly, or packaging processes. Conclusion: an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode. (b)(4).
 
Event Description
It was reported that after a nurse had inserted a bd pegasus¿ safety closed iv catheter system 20g x 1. 16 in. , the catheter broke off in the patient as she removed the needle. The patient had surgery to remove the broken catheter.
 
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Brand NameBD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM 20G X 1.16 IN.
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
8015652845
MDR Report Key6526008
MDR Text Key73830588
Report Number3006948883-2017-00010
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
Report Date 04/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Catalogue Number383742
Device Lot Number6111459
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 Received04/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2016
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: 04/27/2017 Patient Sequence Number: 1
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