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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AS LVP 20D 2SS CV; INTRAVASCULAR ADMINISTRATION SET
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AS LVP 20D 2SS CV; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2420-0007
Device Problems Leak/Splash (1354); Free or Unrestricted Flow (2945)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2021
Event Type  malfunction  
Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed in and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no product or photo was returned by the customer.The customer complaint that the pump segment snapped and disconnected from tubing could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 2420-0007 because a lot number was not provided by the customer.Due to no sample received, an investigation could not be performed and a root cause could not be determined.
 
Event Description
It was reported that a as lvp 20d 2ss cv experienced air in line and component separation during use.The following was reported by the initial reporter: "ivig was administered as ordered.With 40 ml of 600 ml left to administer "air in line" message popped up.Lvip was paused and tubing was inspected for air bubbles.Pump infusion set was removed from pump and tubing was tapped to move air bubbles.When re-inserting pump infusion set, pump segment snapped and disconnected from tubing.Tubing was disconnected from pt and ivig glass vial.Vial was cleansed with alcohol wipe, spiked with new alaris pump infusion set and remaining 40 ml of ivig were administered to pt.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-07-19.Investigation summary: one used primary set, model 2420-0007, was received investigation.Upon visual inspection, it could be observed that the silicon tubing pumping segment had disconnected from the lower fitment.The lower fitment and lower half of the set was not returned.No other defects were observed.The customer's complaint that the pump segment snapped and disconnected from tubing was verified.The expected retainer ring for this engagement was not received as well.A device history record review could not be performed on model 2420-0007 because a lot number was not provided by the customer.Visual inspection under magnification was performed on the silicon pumping segment.Indentation from the retainer ring could be observed, indicating that the retainer ring was properly aligned during the manufacturing process.The root cause of the set separation could not be determined.However, at some point the set may have been pulled or stretched beyond the retention specification between the silicone segment and the set¿s lower fitment during use or set loading.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that a as lvp 20d 2ss cv experienced air in line and component separation during use.The following was reported by the initial reporter: "ivig was administered as ordered.With 40 ml of 600 ml left to administer "air in line" message popped up.Lvip was paused and tubing was inspected for air bubbles.Pump infusion set was removed from pump and tubing was tapped to move air bubbles.When re-inserting pump infusion set, pump segment snapped and disconnected from tubing.Tubing was disconnected from pt and ivig glass vial.Vial was cleansed with alcohol wipe, spiked with new alaris pump infusion set and remaining 40 ml of ivig were administered to pt.".
 
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Brand Name
AS LVP 20D 2SS CV
Type of Device
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12100590
MDR Text Key259422152
Report Number2243072-2021-01798
Device Sequence Number1
Product Code FPA
UDI-Device Identifier37613203021020
UDI-Public37613203021020
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 07/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2021
Initial Date Manufacturer Received 06/02/2021
Initial Date FDA Received07/01/2021
Supplement Dates Manufacturer Received07/20/2021
Supplement Dates FDA Received08/09/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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