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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA II IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER

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BD (SUZHOU) BD INTIMA II IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383019
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 12/17/2020
Event Type  malfunction  
Manufacturer Narrative
There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 0168642. Medical device expiration date: 2023-07-26. Device manufacture date: 2020-06-16. Medical device lot #: 0063910. Medical device expiration date: 2023-07-26. Device manufacture date: 2020-06-16. Medical device lot #: 0907739. Medical device expiration date: 2023-07-26. Device manufacture date: 2020-06-16. 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 90 bd intima ii¿ iv catheter prn adapters from lot 0168642, 13 from lot 0063910, and 11 from lot 0907739 had visible silicone particles in their needles. The following information was provided by the initial reporter, translated from (b)(6) to english: "there was visible sillicon particle in the needle, and several batches were influenced, this incident was happened in the psychiatry department".
 
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Brand NameBD INTIMA II IV CATHETER PRN ADAPTER
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
8015296192
MDR Report Key11168049
MDR Text Key247501451
Report Number3006948883-2021-00073
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383019
Device Lot NumberSEE SECTION H.10.
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 Received02/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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