MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD PRI TUBING

Catalog Number UNKNOWN

Device Problems Complete Blockage (1094); Restricted Flow rate (1248); Leak/Splash (1354); Free or Unrestricted Flow (2945)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/11/2020

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.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: a complaint of tubing vacuumed flat was received from the customer.No product or photo was returned by the customer.The customer complaint of damage could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a model or lot number was not provided by the customer.The root cause of this failure was not identified as no product was returned.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 the unspecified bd pri tubing experienced air in line alarm during use, clogging/blocking/occlusion, and defective/damaged tubing.The following information was provided by the initial reporter: material no.: unknown, batch no.: unknown.Etoposide started per protocol.Pump began to alarm as "air-in-line" and "occluded." upon assessment, the tubing appeared to have issues with venting.The tubing in the channel was vaccumed flat and the chamber was concaved in as well.Infusion stopped.Pharmacy notified.Pharmacy recommended to disconnect and delivered to them.No adverse event or harm to pt.Pt stable.

Event Description

It was reported that the unspecified bd pri tubing experienced air in line alarm during use, clogging/blocking/occlusion, and defective/damaged tubing.The following information was provided by the initial reporter: material no.: unknown batch no.: unknown etoposide started per protocol.Pump began to alarm as "air-in-line" and "occluded." upon assessment, the tubing appeared to have issues with venting.The tubing in the channel was vaccumed flat and the chamber was concaved in as well.Infusion stopped.Pharmacy notified.Pharmacy recommended to disconnect and delivered to them.No adverse event or harm to pt.Pt stable.

Manufacturer Narrative

H.6.Investigation: no product or photo was returned by the customer.The customer complaint of damage could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a model or lot number was not provided by the customer.The root cause of this failure was not identified as no product was returned.H3 other text : see h.10.

• Brand Name: UNSPECIFIED BD PRI TUBING
• Type of Device: PRI TUBING
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10632393
• MDR Text Key: 214812228
• Report Number: 2243072-2020-01570
• Device Sequence Number: 1
• Product Code: FPK
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1 MO