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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOSPIRA INC PRIMARY SYMBIQ SET PIGGYBACK WITH BACKCHECK VALVE; TUBING, FLUID DELIVERY
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HOSPIRA INC PRIMARY SYMBIQ SET PIGGYBACK WITH BACKCHECK VALVE; TUBING, FLUID DELIVERY Back to Search Results
Model Number 1606828
Device Problems Break (1069); Detachment Of Device Component (1104); Residue After Decontamination (2325)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/13/2013
Event Type  malfunction  
Event Description
Patient on surgical nursing unit with bowel obstruction and gastroenteritis was to receive potassium chloride 250 ml bag of 40 meq lidocaine 20 mg of 1% over 4 hours.Iv tubing was connected at the y-site.Rn was attempting to disconnect from the y-site and the end of the tubing snapped off.Broken tubing pieces and y-site hub were saved.There was no harm to the patient.Prevantics swab (chlorohexidine gluconate) 3.5% and isopropyl alcohol (70%) swab antiseptic are used to wipe off the hub of the iv set, leaving a white residue.Rn questions whether the white residue on the hub could have contributed to the tubing break.
 
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Brand Name
PRIMARY SYMBIQ SET PIGGYBACK WITH BACKCHECK VALVE
Type of Device
TUBING, FLUID DELIVERY
Manufacturer (Section D)
HOSPIRA INC
275 north field drive, bldg h2
lake forest IL 60045
MDR Report Key3564230
MDR Text Key17387408
Report Number3564230
Device Sequence Number1
Product Code FPK
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 01/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Model Number1606828
Device Catalogue Number16068-28
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/07/2014
Event Location Hospital
Date Report to Manufacturer01/09/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
USED TO WIPE OFF THE HUB, LEAVING A WHITE RESIDUE; ADDRESS: TWO NICE-PAK PARK, ORANGEBURG, NY 10954.; AND ISOPROPYL ALCOHOL (70%) SWAB ANTISEPTIC ARE; PREVANTICS SWAB (CHLOROHEXIDINE GLUCONATE) 3.5%; NDC 10819-1080-1 REORDER # B10800 MANUFACTURER:; PROFESSIONAL DISPOSABLES INTERNATIONAL INC, (PDI).
Patient Age58 YR
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