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

Catalog Number UNKNOWN

Device Problem Failure to Unfold or Unwrap (1669)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 02/15/2023

Event Type  Injury  

Event Description

It was reported while using an unspecified bd intravascular administration set the tubing was kinked.The following information was provided by the initial reporter: noted tubing was not in air in line sensor guide with kink in tubing roller clamp was not fully seated.Medication in bag cardene 200ml large portion of fluid not in bag with primary administration set in use.Requested staff to keep tubing in pump module and send to clinical engineering along with pcu in use.Patient was hypotensive, attended by medical staff.Noted heart rate was 59, blood pressure 84/56, alert.

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 and the franklin lakes fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

Investigation summary no product or photo was returned by the customer.The customer complaint of tubing kinked 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.

Event Description

It was reported while using an unspecified bd intravascular administration set the tubing was kinked.The following information was provided by the initial reporter: noted tubing was not in air in line sensor guide with kink in tubing roller clamp was not fully seated.Medication in bag cardene 200ml large portion of fluid not in bag with primary administration set in use.Requested staff to keep tubing in pump module and send to clinical engineering along with pcu in use.Patient was hypotensive, attended by medical staff.Noted heart rate was 59, blood pressure 84/56, alert.

• Brand Name: UNSPECIFIED BD INTRAVASCULAR ADMINISTRATION 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: 16537495
• MDR Text Key: 311227123
• Report Number: 2243072-2023-00387
• 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: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: Yes
• 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: 03/20/2023
• 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
• Patient Outcome(s): Required Intervention