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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD INTIMA II¿ IV CATHETER 24G X 0.75 IN. INTERVASCULAR CATHETER

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BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD INTIMA II¿ IV CATHETER 24G X 0.75 IN. INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383423
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/14/2017
Event Type  Injury  
Manufacturer Narrative
Date received by manufacture updated to 6/16/2017. Results- investigation: a sample was not returned for evaluation however a photo was received. A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5245083. Returned materials show reported defect. Customer return photo shows that the residual hose length of about 5mm was bending causing it to possibly stretch. Conclusion: without a sample, 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.
 
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 on the second day of infusion while at home, the child's parent found the bd intima ii¿ iv catheter 24g x 0. 75 in. Broke off in the child. An ultrasound was preformed to locate the catheter. Surgery was preformed to remove the broken catheter.
 
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Brand NameBD INTIMA II¿ IV CATHETER 24G X 0.75 IN.
Type of DeviceINTERVASCULAR CATHETER
Manufacturer (Section D)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
Manufacturer (Section G)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6711422
MDR Text Key109946696
Report Number3006948883-2017-00023
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K100775
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 09/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2018
Device Catalogue Number383423
Device Lot Number5245083
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 Received06/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/16/2015
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: 07/13/2017 Patient Sequence Number: 1
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