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

Catalog Number UNKNOWN

Device Problem Free or Unrestricted Flow (2945)

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

Event Date 05/11/2021

Event Type  malfunction  

Manufacturer Narrative

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 (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that an unspecified bd device experienced air in line during use.The following was reported by the initial reporter: "rn responded to patient's call light due to a pump while she was conducting q@h turns.Nurse saw the iv pump module latch was slightly open and discovered the large circular distended bubble in the iv tubing.Rn notified (b)(6), rn the primary nurse for the patient, and quickly paused the pca pump, notified the unit educator, charge nurse, and paged psrt.".

Event Description

It was reported that an unspecified bd device experienced air in line during use.The following was reported by the initial reporter: "rn responded to patient's call light due to a pump while she was conducting q@h turns.Nurse saw the iv pump module latch was slightly open and discovered the large circular distended bubble in the iv tubing.Rn notified xxxxxx, rn the primary nurse for the patient, and quickly paused the pca pump, notified the unit educator, charge nurse, and paged psrt.".

Manufacturer Narrative

H.6.Investigation: no product or photo was returned by the customer.The customer complaint that they discovered a large circular distended bubble in the iv tubing 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 and 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.

• Brand Name: UNSPECIFIED BD DEVICE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11963519
• MDR Text Key: 255990378
• Report Number: 2243072-2021-01639
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• 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
• Date Manufacturer Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1