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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER

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BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383033
Device Problem Contamination (1120)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/08/2018
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 with the use of the bd intima-ii¿ closed iv catheter system there was an issue with foreign matter. There was no report of 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: yes. A review of the device history record revealed no irregularities during the manufacture of the reported lot. One sample was returned in an unopened package. There is viible rust on the middle of the needle cover. Samples were received in flks to complete ftir testing on the reddish material observed in the lumen of the cannula. A small portion of this material was removed from the sample and prepared for ftir spectral analysis. No results were acquired from the ftir analysis which indicates that the reddish material is metallic in nature. This material was then prepared for sem/edx analysis. This analysis yields an elemental breakdown of the material. The analysis shows that this material contains iron, chromium, carbon, and nickel, all of which are components of steel. The chlorine and oxygen are most likely from saline. The silicon and carbon are most likely from the silicone that is present on the surface of the cannula. All of this information indicates that the reddish material is rust. Strong oxidizing or humid environment cause product rust, this defect is related to the product transfer subsequent transportation and storage.
 
Event Description
It was reported with the use of the bd intima-ii closed iv catheter system there was an issue with foreign matter. There was no report of injury or medical intervention.
 
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Brand NameBD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
MDR Report Key7811089
MDR Text Key118401333
Report Number3006948883-2018-00155
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 09/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/24/2021
Device Catalogue Number383033
Device Lot Number8017220
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/23/2018 Patient Sequence Number: 1
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