MAUDE Adverse Event Report: BECTON DICKINSON AS LVP 20D 2SS CV; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 2420-0007

Device Problems Complete Blockage (1094); Restricted Flow rate (1248); Infusion or Flow Problem (2964)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 09/18/2020

Event Type  Injury  

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 in and the franklin lakes 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¿ tubing ballooned and was occluded.The following information was provided by the initial reporter: material no: unknown batch no: unknown it was reported that bd iv tubing ballooned.Per customer email: discussed this at their facility on the 18th, has tubing in hand just today to keep for return.Tubing ballooned out between two chambers that go into pump module; was discovered while in the pump; it was occluded with pump alarm but it did not separate or leak.

Manufacturer Narrative

The following fields were updated due to additional information: b.5.Describe event or problem: it was reported that as lvp 20d 2ss cv ballooned and was occluded.The following information was provided by the initial reporter: material no: unknown batch no: unknown it was reported that bd iv tubing ballooned.Per customer email: discussed this at their facility on the 18th, has tubing in hand just today to keep for return.Tubing ballooned out between two chambers that go into pump module; was discovered while in the pump; it was occluded with pump alarm but it did not separate or leak.D.1.Medical device brand name: as lvp 20d 2ss cv d.4.Medical device catalog #: 2420-0007 d.4.Unique identifier (udi) #: (b)(4) g.5.Pma / 510(k)#: k944320 h.6.Investigation: one sample was returned for investigation by the customer.It was reported that bd iv tubing ballooned.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was primed, and then infused with the pump dchu-0009 and pump module dchu-0015 at 100 ml / hr.No ballooning occurred throughout the infusion, or after the infusion.The complaint could not be verified and the failure was unable to be replicated.A device history record review could not be performed on model 2420-0007 because a lot number was not provided by the customer.The root cause of this failure could not be identified because the failure was unable to be replicated.See h.10.

Event Description

It was reported that as lvp 20d 2ss cv ballooned and was occluded.The following information was provided by the initial reporter: material no: unknown batch no: unknown it was reported that bd iv tubing ballooned.Per customer email: discussed this at their facility on the 18th, has tubing in hand just today to keep for return.Tubing ballooned out between two chambers that go into pump module; was discovered while in the pump; it was occluded with pump alarm but it did not separate or leak.

• Brand Name: AS LVP 20D 2SS CV
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10694558
• MDR Text Key: 212077475
• Report Number: 2243072-2020-01670
• Device Sequence Number: 1
• Product Code: FPA
• 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: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2420-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/17/2020
• Supplement Dates Manufacturer Received: 11/09/2020
• Supplement Dates FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR