MAUDE Adverse Event Report: BD MEDICAL, MEDICATION DELIVERY SOLUTIONS UNSPECIFIED BD INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problem Backflow (1064)

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

Event Date 09/13/2023

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.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.B3.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that unspecified bd infusion set had flow issues.It was the following information was provided by the initial reporter with verbatim: customer reports that a lot of times they see blood backing up in the line while administering a-line infusions.Their procedure is as follows: for patients less than 25 kilos they use the pump module and run 3-5ml/hr.For patients greater than 40 kilos they use a pressure bag.For patients between 25-40 kilos it is a case by case basis.They are seeing the blood in the tubing normally with the pump module scenario.

Manufacturer Narrative

H.6.Investigation summary: a complaint of blood backing up into tubing was received from the customer.No product or photo was returned by the customer.The customer complaint of blood backs up/ not completely expelled 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.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

Event Description

It was reported that unspecified bd infusion set had flow issues.It was the following information was provided by the initial reporter with verbatim: customer reports that a lot of times they see blood backing up in the line while administering a-line infusions.Their procedure is as follows: for patients less than 25 kilos they use the pump module and run 3-5ml/hr.For patients greater than 40 kilos they use a pressure bag.For patients between 25-40 kilos it is a case by case basis.They are seeing the blood in the tubing normally with the pump module scenario.

• Brand Name: UNSPECIFIED BD INFUSION SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17831390
• MDR Text Key: 324463849
• Report Number: 2243072-2023-01733
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• 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: 10/04/2023
• 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