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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
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BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM Back to Search Results
Catalog Number 383033
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Abrasion (1689); Infiltration into Tissue (1931); Local Reaction (2035)
Event Date 07/08/2019
Event Type  Injury  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd intima-ii¿ closed iv catheter system was used and the patient had a skin reaction.This was discovered during use.The following information was provided by the initial reporter: on july 1, the patient was admitted to hospital according to the emergency plan of "left calf soft tissue file abrasion".After admission, the patient was treated with intravenous infusion with indwelling needle in the left forearm (apricotine).On july 3, the indwelling needle eye was slightly red, and the indwelling needle was removed.On the morning of july 4, the patient's left forearm indwelling needle eye was red, with local indwelling, damage, and a small amount of infiltration, with a range of about 1.5cm*1.5cm.On july 5, the indwelling needle infusion was given to the right wrist, and the indwelling needle was removed at 17:00 p.M.On the morning of july 6, 1cm*1cm skin redness and a small amount of exudation were observed at the puncture site of the indwelling needle in the right wrist.After consultation, the ulcer was applied for external use.
 
Event Description
It was reported that bd intima-ii¿ closed iv catheter system was used and the patient had a skin reaction.This was discovered during use.The following information was provided by the initial reporter: on july 1, the patient was admitted to hospital according to the emergency plan of "left calf soft tissue file abrasion".After admission, the patient was treated with intravenous infusion with indwelling needle in the left forearm (apricotine).On july 3, the indwelling needle eye was slightly red, and the indwelling needle was removed.On the morning of july 4, the patient's left forearm indwelling needle eye was red, with local indwelling, damage, and a small amount of infiltration, with a range of about 1.5cm*1.5cm.On july 5, the indwelling needle infusion was given to the right wrist, and the indwelling needle was removed at 17:00 p.M.On the morning of july 6, 1cm*1cm skin redness and a small amount of exudation were observed at the puncture site of the indwelling needle in the right wrist.After consultation, the ulcer was applied for external use.
 
Manufacturer Narrative
Investigation summary a device history review was conducted for lot number 8233335.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, a sample could not be obtained for evaluation and testing, but this lot was treated and received a certificate of conformance for sterility.Unfortunately, without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue.
 
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Brand Name
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
Type of Device
CATHETER
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
MDR Report Key9526389
MDR Text Key182211902
Report Number3006948883-2019-01131
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,other,user facility
Type of Report Initial,Followup
Report Date 01/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/04/2021
Device Catalogue Number383033
Device Lot Number8233335
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/11/2019
Initial Date FDA Received12/27/2019
Supplement Dates Manufacturer Received12/11/2019
Supplement Dates FDA Received01/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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