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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 20 INCH EXT SET INTRAVASCULAR ADMINISTRATION SET

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CAREFUSION 20 INCH EXT SET INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number C20022
Device Problem Leak/Splash (1354)
Patient Problem Missed Dose (2561)
Event Date 08/03/2020
Event Type  Injury  
Manufacturer Narrative
Date of birth: unknown. The patient¿s age was used to determine a placeholder date for this field. Weight: (b)(6) kilograms. 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 20 inch ext set broke off in the lumen of the picc line. The following information was provided by the initial reporter: material no: c20022 , batch no: 20056787. It was reported that the tip of the tubing broke off in the lumen due to difficulty removing extension sets. Customer response 31-aug-2020: "the male piece from the extension tubing broke off in the picc line. Please see my responses to your questions below: additionally please advise on the additional inquiry regarding the adverse event: could you provide confirmation that the line was a central line and not a peripheral line? additionally, did it need to be replaced? this was a picc line which had to be removed; we placed a peripheral iv as the patient¿s antibiotic therapy was not completed. Pt had 3 more days of antibiotic therapy. Because the medication regimen was completed 3 days early, were any doses of medication missed? this is not accurate. The patient¿s medication regimen was not complete¿pt. Had 3 more days of therapy. " customer response 25-aug-2020: are you able to provide a part no and batch no for the reported extension tubing? ref# c20022, lot# (10)20056787. Was there any adverse event(s) as a result of the reported defect? yes pt. ¿s picc line had to be removed prematurely" event information: date of occurrence: (b)(6) 2020. What type of catheter securement was utilized? statlock. A more detailed description of the event: the patient¿s extension tubing was being changed out, and when the nurse tried to disconnect tubing from the lumen, the tip of the tubing broke off in the lumen. Since switching to bd tubing and extensions, staff have noticed that it is difficult to remove extension sets during dressing changes. Iv therapy¿s staff is very aware of alcohol dry time, so this most likely is not the cause. Staff have commented that all patients who have extension added to their lines are having difficulty removing the tubing¿some have had to use tourniquets to grip. Was the bard product used on a patient?: the bd product was used. Was there patient harm reported?:no, however, the patient¿s picc line had to be removed 3 days before treatment regimen completed. What they¿re being treated for: right calcaneal osteomyelitis ((b)(6)). Other relevant history: no other medical history. Concomitant therapy: n/a.
 
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Brand Name20 INCH EXT SET
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 s state st
sandy UT 84070 3213
Manufacturer Contact
brett wilko
9450 s state st
sandy, UT 84070-3213
8015652341
MDR Report Key10486232
MDR Text Key205499219
Report Number9616066-2020-02629
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K790108
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberC20022
Device Catalogue NumberC20022
Device Lot Number20056797
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/02/2020 Patient Sequence Number: 1
Treatment
C20022, 20200803, MZ1000-07
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