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

Catalog Number UNKNOWN

Device Problem Partial Blockage (1065)

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

Event Date 04/06/2023

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.Medical device expiration date: unknown.H.3.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 an unspecified number of unspecified bd alaris¿ infusion sets had issues with inaccurate flow rates during use due to the tubing not loading properly.The following information was provided by the initial reporter: "requesting an alarm when the tubing is not loaded properly.1.What is the user experiencing? current pumps are older and do not have the wording "load first" inside the lvp.Noticing tubing is not loaded properly.2.How is this impacting workflow or patient care? infusions may be running too fast or too slow.3.What value are they looking for? accurate flow rates.An alert to the nurse.4.Have they implemented work arounds? they have the tip sheet and have communicated proper loading to their nurses.5.What is their specific request? an alarm when the tubing is not loaded properly or a way for the pump to not allow programming the infusion unless the tubing is loaded properly.".

Event Description

It was reported that an unspecified number of unspecified bd alaris¿ infusion sets had issues with inaccurate flow rates during use due to the tubing not loading properly.The following information was provided by the initial reporter: "requesting an alarm when the tubing is not loaded properly.1.What is the user experiencing? current pumps are older and do not have the wording "load first" inside the lvp.Noticing tubing is not loaded properly.2.How is this impacting workflow or patient care? infusions may be running too fast or too slow.3.What value are they looking for? accurate flow rates.An alert to the nurse.4.Have they implemented work arounds? they have the tip sheet and have communicated proper loading to their nurses.5.What is their specific request? an alarm when the tubing is not loaded properly or a way for the pump to not allow programming the infusion unless the tubing is loaded properly.".

Manufacturer Narrative

Investigation summary: no product or photo was returned by the customer.It was reported by the customer that the infusions may be running too fast or too slow.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because model and lot numbers are unknown.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

• Brand Name: UNSPECIFIED BD ALARIS¿ 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16829182
• MDR Text Key: 314168668
• Report Number: 2243072-2023-00687
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 05/10/2023
• Supplement Dates FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1