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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II Y 24GAX0.75IN MZ PRN SLM NPVC; INTERVASCULAR CATHETER
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BD (SUZHOU) INTIMA-II Y 24GAX0.75IN MZ PRN SLM NPVC; INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383284
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/10/2020
Event Type  malfunction  
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 intima-ii y 24gax0.75in mz prn slm npvc experienced a loose end cap.The following information was provided by the initial reporter: the positive pressure connector fell off accidentally during infusion adr# (b)(4).
 
Manufacturer Narrative
H6: investigation summary: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this incident and the findings.A review of the device history record was performed and no quality issues were found during production.H3 other text : see h.10.
 
Event Description
It was reported that the intima-ii y 24gax0.75in mz prn slm npvc experienced a loose end cap.The following information was provided by the initial reporter: the positive pressure connector fell off accidentally during infusion adr# (b)(4).
 
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Brand Name
INTIMA-II Y 24GAX0.75IN MZ PRN SLM NPVC
Type of Device
INTERVASCULAR CATHETER
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
MDR Report Key11103505
MDR Text Key224855239
Report Number3006948883-2020-01087
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 01/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/10/2022
Device Catalogue Number383284
Device Lot Number9298543
Was Device Available for Evaluation? No
Date Manufacturer Received01/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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