MAUDE Adverse Event Report: BECTON DICKINSON AS LVP 20D 3SS CV; IV SET

Catalog Number 2426-0007

Device Problem Free or Unrestricted Flow (2945)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and 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 and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that unspecified bd¿ iv set had air inside.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported that there was air found in the iv set.Clinical advocacy intake form: the lvp was pumping air into the iv set when med bag was empty.Found a small drop of fluid in tubing where the air in line sensor is allowing the lvp to run.Nurse stopped before air reached pt.

Event Description

It was reported that as lvp 20d 3ss cv had air inside.The following information was provided by the initial reporter: material no: unknown.Batch no: unknown.It was reported that there was air found in the iv set.Clinical advocacy intake form: the lvp was pumping air into the iv set when med bag was empty.Found a small drop of fluid in tubing where the air in line sensor is allowing the lvp to run.Nurse stopped before air reached pt.

Manufacturer Narrative

The following fields were updated due to additional information: b.5.Describe event or problem: it was reported that as lvp 20d 3ss cv had air inside.The following information was provided by the initial reporter: material no: unknown.Batch no: unknown.It was reported that there was air found in the iv set.Clinical advocacy intake form: the lvp was pumping air into the iv set when med bag was empty.Found a small drop of fluid in tubing where the air in line sensor is allowing the lvp to run.Nurse stopped before air reached pt.D.1.Medical device brand name: as lvp 20d 3ss cv d.4.Medical device catalog #: 2426-0007.D.4.Unique identifier (udi) #: (b)(4).G.5.Pma / 510(k)#: k944320.H.6.Investigation: one sample was returned by the customer.It was reported that there was air found in the iv set.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was successfully primed.The set was infused with the bd alaris pump module at 125 ml/hr with a vtbi of 125 ml.No air bubbles were observed in the tubing throughout the infusion.There were no alarms.The infusion was completed successfully.The failure was unable to be replicated.A device history record review could not be performed on model 2426-0007 because a lot number was not provided by the customer.A root cause was unable to be determined because the failure was unable to be replicated.H3 other text : see h.10.

• Brand Name: AS LVP 20D 3SS CV
• Type of Device: IV SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10870477
• MDR Text Key: 225008138
• Report Number: 2243072-2020-01880
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2426-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1