MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SEC TUBING DEVICE; EXTENSION SET

Catalog Number UNKNOWN

Device Problem Free or Unrestricted Flow (2945)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

Date of birth: only the patient's age was provided therefore a default date of birth has been listed.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.Unknown manufacturer: 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 sec tubing device experienced air bubbles/air in line.The following information was provided by the initial reporter: customer response to acknowledgement and info request 1: correct- no harm detected do you happen to have a specific date for this incident? (b)(6) 2020.Iv tylenol from 1800 did not infuse into patient via secondary tubing and the patient said the day shift rn was having issues getting it to infuse that way as well.I switched the tylenol to the extension set tubing using a second pump and connected the line to the primary ns fluids, i primed the line well before connecting with no bubbles.After the tylenol was completed, my nurse aid who was walking the patient at the time let me know and when i came into the patients room there was moderate size air bubbles in the line originating from the short set iv tubing's pump where the tylenol had ran dry and continued to infuse without alarming that there is air in the line.I immediately stopped the infusing and disconnected the patient then notified my charge rn and have since closely monitored the patient.The lvp pump which the tylenol was infusing through expires this month and was taken out of the room and marked defective.

Manufacturer Narrative

H.6 investigation summary: one photo was received our quality team for evaluation.Upon visual inspection of the photo, there were no signs of moderate sized bubble; therefore, the incident could not be verified.A device history record review could not be performed because a model or lot number was not provided by the customer.A root cause could not be determined due to no sample being received and an investigation not being able to be performed.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: one photo received but could not verify incident based on photo.No product will be returned per customer.No investigation was performed.Root cause description: a root cause could not be determined due to no sample being received and an investigation not being able to be performed.

Event Description

It was reported that the unspecified bd sec tubing device experienced air bubbles/air in line.The following information was provided by the initial reporter: customer response to acknowledgement and info request 1: correct- no harm detected do you happen to have a specific date for this incident? (b)(6) 2020 iv tylenol from 1800 did not infuse into patient via secondary tubing and the patient said the day shift rn was having issues getting it to infuse that way as well.I switched the tylenol to the extension set tubing using a second pump and connected the line to the primary ns fluids, i primed the line well before connecting with no bubbles.After the tylenol was completed, my nurse aid who was walking the patient at the time let me know and when i came into the patients room there was moderate size air bubbles in the line originating from the short set iv tubing's pump where the tylenol had ran dry and continued to infuse without alarming that there is air in the line.I immediately stopped the infusing and disconnected the patient then notified my charge rn and have since closely monitored the patient.The lvp pump which the tylenol was infusing through expires this month and was taken out of the room and marked defective.

• Brand Name: UNSPECIFIED BD SEC TUBING DEVICE
• Type of Device: EXTENSION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton dr; franklin lakes NJ 07417 1815
• MDR Report Key: 10242381
• MDR Text Key: 209438154
• Report Number: 9616066-2020-02184
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/07/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 20200604; 8100, 8015, 2204-0007, 2426-0007
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 101