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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA II PLUS¿ CATHETER

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BD (SUZHOU) BD INTIMA II PLUS¿ CATHETER Back to Search Results
Catalog Number 383426
Device Problem Contamination (1120)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/28/2018
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.
 
Event Description
It was reported that a bd intima ii plus¿ had foreign matter in the tubing. There was no report of exposure, serious injury or medical intervention.
 
Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields. This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacture: no. The batch record for lot#7265023 was reviewed, no related abnormalities were found during the manufacturing process. The actual sample was provided by the customer for this complaint. The actual sample was evaluated and did show the reported failure mode in which confirmed this complaint. The extension tubing of the returned sample, bd engineers noted a red foreign matter in the extension tubing of the device. As per request, ftir analysis was completed on the reddish material observed in the tubing of the sample. A small portion of this material was removed from the sample and prepared for ftir spectral analysis. The spectral analysis shows that this material is most likely blood along with human skin flake. Root cause cannot be confirmed.
 
Event Description
It was reported that a bd intima ii plus had foreign matter in the tubing. There was no report of exposure, serious injury or medical intervention.
 
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Brand NameBD INTIMA II PLUS¿
Type of DeviceCATHETER
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
MDR Report Key7807549
MDR Text Key118104995
Report Number3006948883-2018-00150
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 09/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/09/2020
Device Catalogue Number383426
Device Lot Number7265023
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/22/2018 Patient Sequence Number: 1
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