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U.S. Department of Health and Human Services

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

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BD (SUZHOU) BD INTIMA-II¿ CATHETER INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383078
Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/25/2018
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¿ catheter had leakage due to slim pinch clamp that is crooked and loose. This clamp does not effectively seal the tube. There was no report of exposure, serious injury or medical intervention.
 
Event Description
It was reported that a bd intima-ii catheter had leakage due to slim pinch clamp that is crooked and loose. This clamp does not effectively seal the tube. There was no report of exposure, serious injury or medical intervention.
 
Manufacturer Narrative
The batch record for lot#8017209 was reviewed, no related abnormalities were found during the manufacturing process. A sample and photo were received for the purpose of our investigation. The investigators were able to observe the reported failure mode in the sample provided, with both the sample and photos provided show that the pinch clamp of the unit was only partially activated. Inspection of the pinch clamp's parameters found the component to be conforming to product specifications. Bd will continue to track and trend for this issue.
 
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Brand NameBD INTIMA-II¿ CATHETER
Type of DeviceINTERVASCULAR CATHETER
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
MDR Report Key7782750
MDR Text Key117268134
Report Number3006948883-2018-00149
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,Followup
Report Date 09/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/28/2021
Device Catalogue Number383078
Device Lot Number8017209
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/14/2018 Patient Sequence Number: 1
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