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

Catalog Number UNKNOWN

Device Problem Improper Flow or Infusion (2954)

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

Event Date 01/30/2023

Event Type  malfunction  

Event Description

It was reported that the unspecified bd infusion set experienced flow issue.The following information was provided by the initial reporter: i have shared your tips and tricks with our team, these have been helpful to ensure there is nothing that we have been doing to affect flow and effective administration, however, we are still consistently having the same issues (drug flowing from both the primary and secondary tubing at the same time) which is causing significant challenges for nursing and the patients, affecting both chair time and increasing drug delivery time (this happens daily).Last week, we had a 3 hr drug infusion that resulted in an extra hour of infusion time and ultimately had to change the primary bag and pinch off the line to ensure drug was consistently dripping from the secondary line (in addition to changing pumps and channels etc.And 4 drug hangers).

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.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 and the franklin lakes fda registration number has been used for the manufacture report number.

Event Description

It was reported that the unspecified bd infusion set experienced flow issue.The following information was provided by the initial reporter: xxxxx, i have shared your tips and tricks with our team, these have been helpful to ensure there is nothing that we have been doing to affect flow and effective administration, however, we are still consistently having the same issues (drug flowing from both the primary and secondary tubing at the same time) which is causing significant challenges for nursing and the patients, affecting both chair time and increasing drug delivery time (this happens daily).Last week, we had a 3 hr drug infusion that resulted in an extra hour of infusion time and ultimately had to change the primary bag and pinch off the line to ensure drug was consistently dripping from the secondary line (in addition to changing pumps and channels etc.And 4 drug hangers).

Manufacturer Narrative

H6: investigation summary no product or photo was returned by the customer.It was reported by the customer that they had a "3 hr drug infusion that resulted in an extra hour of infusion time.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.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16433295
• MDR Text Key: 310252041
• Report Number: 2243072-2023-00258
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: UNKNOWN
• 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: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• 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: 03/03/2023
• 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