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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 7-IN PRESSURE RATED SET W/ MAXPLUS; INTRAVASCULAR ADMINISTRATION SET
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CAREFUSION 7-IN PRESSURE RATED SET W/ MAXPLUS; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number MP5303-C
Device Problems Leak/Splash (1354); Difficult to Remove (1528); Difficult or Delayed Separation (4044)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/09/2020
Event Type  malfunction  
Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 20015080.Medical device expiration date: 2025-01-04.Device manufacture date: 2020-01-04.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.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 7-in pressure rated set w/ maxplus was difficult to disconnect and then leaked.The following information was provided by the initial reporter: material no: mp5303-c batch no: 20015080.It was reported that the extension set leaked at connector with contrast tubing.Additional events with unknown lot no's, but no product for return.I received complaints from the ct technologists regarding the md maxplus extension set this morning.They say they have been having trouble unscrewing the contrast tubing from the extension set after injection.They also have had some leaking at between the extension set connector and contrast tubing, saying they double checked it wasn¿t cross threaded and could not figure out what the issue was.I asked them to save the tubing and packaging next time it happens.They have multiple lot numbers in their supply carts.
 
Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of leakage could not be verified due to the product not being returned for failure investigation.A device history record review for model mp5303-c lot number 20015080 was performed.The search showed that a total of 12803 units in 1 lot number was built on 04jan2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review could not be performed on the set from model mp5303-c because a lot number was not provided by the customer.The root cause of this failure was not identified as no product was returned.This incident has been added to our database of reported incidents.
 
Event Description
It was reported that 7-in pressure rated set w/ maxplus was difficult to disconnect and then leaked.The following information was provided by the initial reporter: material no: mp5303-c batch no: 20015080.It was reported that the extension set leaked at connector with contrast tubing.Additional events with unknown lot no's, but no product for return.I received complaints from the ct technologists regarding the md maxplus extension set this morning.They say they have been having trouble unscrewing the contrast tubing from the extension set after injection.They also have had some leaking at between the extension set connector and contrast tubing, saying they double checked it wasn¿t cross threaded and could not figure out what the issue was.I asked them to save the tubing and packaging next time it happens.They have multiple lot numbers in their supply carts.
 
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Brand Name
7-IN PRESSURE RATED SET W/ MAXPLUS
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key10233414
MDR Text Key197612827
Report Number9616066-2020-02039
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403236655
UDI-Public10885403236655
Combination Product (y/n)N
PMA/PMN Number
K051499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 06/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMP5303-C
Device Catalogue NumberMP5303-C
Device Lot NumberSEE H.10
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
20200609; 20200609; 01-01-2020
Patient Outcome(s) Other;
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