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

Catalog Number 2426-0500

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 09/18/2023

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 franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4 device expiration date: unknown h3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that the unspecified bd¿ infusion set end cap missing.The following information was provided by the initial reporter: recently one of the rns were priming an infusion set and noticed the end cap was missing ¿ the end where the patient would be connected to.This occurred in the cvicu, where patients can be very dependent on iv medication to maintain blood pressure, which we infuse through the alaris infusion set.

Manufacturer Narrative

One photo was received for quality investigation.The customer complaint of misassembly - end cap missing was confirmed by investigation of the photo received.Evaluation of the photo received shows that the tubing was missing the component that should be at the end of the infusion set tubing.A device history record review could not be performed because the lot number is unknown.A root cause could not be determined because a physical sample was not provided for analysis.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

No additional information.Material #: unknown , batch #: unknown.It was reported by the customer that one of the rns were priming an infusion set and noticed the end cap was missing ¿ the end where the patient would be connected to.Verbatim: she is a nursing educator at unity health toronto, st.Michael¿s site.Recently one of the rns were priming an infusion set and noticed the end cap was missing ¿ the end where the patient would be connected to.This occurred in the cvicu, where patients can be very dependent on iv medication to maintain blood pressure, which we infuse through the alaris infusion set.Response received on 03-oct-2023: 1.Are you able to provide the product number and the batch number? the mpn in our hospital is: al2426-0500.Full name of tubing is ¿set iv 3 port prim 20 drp 321cm.¿ no batch number at this time.2.Was there any patient involvement? no, it was being primed to then be connected to the patient.3.Was there any adverse event or serious injury? no.4.Please confirm the quantity of defective set inspected.Only one was identified as defective 5.How was the issue resolved? defected tubing was discarded by the nurse ¿ they took a photo and notified myself, the educator of the unit.6.Is sample available to be return for investigation? no, it was discarded.7.Is any photo of incident able to be provide? please see above.8.Are you able to provide the date of incident? september 18, 2023 ¿ photo taken at 5:41pm.

• Brand Name: UNSPECIFIED BD¿ INFUSION SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17917052
• MDR Text Key: 325843653
• Report Number: 2243072-2023-01829
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021006
• UDI-Public: (01)37613203021006
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2426-0500
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1