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 Insufficient Information (4580)

Event Date 09/12/2023

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 bd unspecified bd infusion set had flow issues.The following information was received by the initial reporter with the verbatim: this had to be reprogrammed twice before it was noted fluid was pulling from the primary saline line not the secondary medication line refer above for mds-isd issue.I have another report but again, no tubing or product lot number to share.Primary bd alaris primary pump tubing (500ml saline bag).Bd secondary med line set (pump tubing) secondary line infusing a chemo medication.When secondary line beeped to indicate completion, the nurse re-programmed to ensure all drug infused.This had to be reprogrammed twice, before it was noted that the fluid was pulling from the primary saline line not the secondary medication line.Nurse found the primary line to be almost empty so hung an addition 250ml bag of saline, the remaining secondary medication infused correctly.

Event Description

It was reported that bd unspecified bd infusion set had flow issues.The following information was received by the initial reporter with the verbatim: this had to be reprogrammed twice before it was noted fluid was pulling from the primary saline line not the secondary medication line refer above for mds-isd issue.I have another report but again, no tubing or product lot number to share.Primary bd alaris primary pump tubing (500ml saline bag).Bd secondary med line set (pump tubing) secondary line infusing a chemo medication.When secondary line beeped to indicate completion, the nurse re-programmed to ensure all drug infused.This had to be reprogrammed twice, before it was noted that the fluid was pulling from the primary saline line not the secondary medication line.Nurse found the primary line to be almost empty so hung an addition 250ml bag of saline, the remaining secondary medication infused correctly.

Manufacturer Narrative

Investigation summary no product or photo was returned by the customer.The customer complaint of flow issues - back flow could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because the lot number is 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 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: 17835284
• MDR Text Key: 324492826
• Report Number: 2243072-2023-01722
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

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: 10/13/2023
• 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