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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION EXTENSION SET SET,EXTENSION,INTRAVASCULAR

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CAREFUSION EXTENSION SET SET,EXTENSION,INTRAVASCULAR Back to Search Results
Model Number 10012143
Device Problems Fluid Leak (1250); Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Although requested, device has not been received. A follow up report will be submitted with failure investigation results should the device be received for evaluation.
 
Event Description
The customer reported a leak while the product was attached to a patient. There was no report of patient harm.
 
Event Description
The customer reported a leak while the product was attached to a patient. There was no report of patient harm. The product was then received with a note stating, "crack where syringe connected to tubing".
 
Manufacturer Narrative
Concomitant medical products: 10ml bd syringe, ref (b)(4), lot number 8018972, exp 2020-12-31, 0. 9% sodium chloride. The device has been received and the evaluation is pending. A follow up report will be submitted with investigation results once the evaluation has been completed.
 
Manufacturer Narrative
The customer¿s report of leaking was confirmed. During visual inspection a residual red/brown substance resembling blood was observed in the set. A vertical crack around 14mm in length was visible on the female luer, extending from the luer opening and down into the luer body. A vertical micro-fracture leading into the larger vertical crack was also observed on the luer body. Functional testing showed a leak at the connection of the syringe to female luer of the set. The root cause of the customer's report was a result of multiple contributing factors such as material regrind, gate location and the effect of chemical agents on mechanical connections of the luer.
 
Event Description
The customer reported a leak while the product was attached to a patient. There was no report of patient harm. The product was then received with a note stating, "crack where syringe connected to tubing".
 
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Brand NameEXTENSION SET
Type of DeviceSET,EXTENSION,INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key7867031
MDR Text Key119930402
Report Number9616066-2018-01651
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup
Report Date 08/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/22/2019
Device Model Number10012143
Device Catalogue Number10012143
Device Lot Number16027066
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2018
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/11/2018 Patient Sequence Number: 1
Treatment
8100,8015, TD UNK; BD POSIFLUSH 10ML SYRINGE; PRI TUBING, TD UNK
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