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

Catalog Number UNKNOWN

Device Problem Failure to Deliver (2338)

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

Event Date 12/28/2022

Event Type  malfunction  

Manufacturer Narrative

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).Medical device expiration date: unknown.Device manufacture date: unknown.Initial reporter name and address: address information was not able to be obtained, therefore, nj was used as a place holder.Device evaluated by mfr: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using an unspecified bd alaris extension set there were flow issues.There was no report of patient impact.The following information was provided by the initial reporter: sometimes when we are infusing medications, the alaris pump stops the infusion and notifies us that there is an occlusion from the drug side (not the patient side).When this happens, we can see that the infusion bag containing the medication is depleted of the air inside but not of the fluid volume.It is important to get the remaining fluid volume to the patient.

Manufacturer Narrative

H6: investigation summary no product or photo was returned by the customer.It was reported by the customer that the alaris pump stops the infusion and notifies us that there is an occlusion from the drug side, and the infusion bag containing the medication is depleted of the air inside but not of the fluid volume.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.H3 other text : see h10.

Event Description

It was reported while using an unspecified bd alaris extension set there were flow issues.There was no report of patient impact.The following information was provided by the initial reporter: sometimes when we are infusing medications, the alaris pump stops the infusion and notifies us that there is an occlusion from the drug side (not the patient side).When this happens, we can see that the infusion bag containing the medication is depleted of the air inside but not of the fluid volume.It is important to get the remaining fluid volume to the patient.

• Brand Name: UNSPECIFIED BD ALARIS EXTENSION 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 ; 8015296192
• MDR Report Key: 16231082
• MDR Text Key: 308534540
• Report Number: 2243072-2023-00054
• 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: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2023
• 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