MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD TUBING; INTRAVASCULAR ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problem Free or Unrestricted Flow (2945)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2020

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" tubing had a check valve malfunction.The following information was provided by the initial reporter: material no: 2420-0007 batch no: 20075382.It was reported that once line was placed into the pump, the primary bag of ns continued to fill the systemic therapy bag with ns.Verbatim: date of incident (yyyy-mm-dd): (b)(6) 2020.Type of incident/problem: malfunction, during or after use.Level of harm: no effect, did not reach patient, detected before use or does not touch person during use.Ahs optional report to cmdsnet ((b)(6)): yes.Incident details: infusion nurse was administering chemotherapy to patient.Systemic agent was attached to the y-site port below the drip chamber and back flow priming of secondary tubing was complete.Once line was placed into the alaris pump the primary bag of ns continued to fill the systemic therapy bag with ns.Nurse noticed immediately and clamped secondary to stop back flow from occurring.With back flow continuing the systemic bag would fill and dilute drug further therefore patient would receive more fluids that are not required.Secondary tubing removed and placed on new line for administration.Who was affected? no person affected.Frequency of problem: recurring.

Event Description

It was reported that unspecified bd¿ tubing had a check valve malfunction.It was reported that once line was placed into the pump, the primary bag of ns continued to fill the systemic therapy bag with ns.Verbatim: date of incident (yyyy-mm-dd): 2020(b)(6) type of incident/problem: malfunction - during or after use level of harm: no effect - did not reach patient - detected before use or does not touch person during use ahs optional report to cmdsnet (health canada): yes incident details: infusion nurse was administering chemotherapy to patient.Systemic agent was attached to the y-site port below the drip chamber and back flow priming of secondary tubing was complete.Once line was placed into the alaris pump the primary bag of ns continued to fill the systemic therapy bag with ns.Nurse noticed immediately and clamped secondary to stop back flow from occurring.With back flow continuing the systemic bag would fill and dilute drug further therefore patient would receive more fluids that are not required.Secondary tubing removed and placed on new line for administration.Who was affected? no person affected frequency of problem: recurring.

Manufacturer Narrative

H6: investigation summary one photo was received from the customer which verifies the customer complaint that once line was placed into the pump, the primary bag of ns continued to fill the systemic therapy bag with ns.No product was returned.A device history review could not be completed as no batch number was provided.H3 other text : see h.10.

• Brand Name: UNSPECIFIED BD TUBING
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11102218
• MDR Text Key: 227074069
• Report Number: 2243072-2020-02257
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1