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

Catalog Number UNKNOWN

Device Problem Stretched (1601)

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

Event Date 02/21/2021

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.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.

Event Description

It was reported that the unspecified bd intravascular administration set experienced tubing expansion/ballooning/bulging.The following information was provided by the initial reporter: material #: unknown, batch/ lot #: unknown.Mid-infusion, alaris pump began alarming "channel error." after opening the channel door an abnormal bulge of fluid was observed in the tubing.

Event Description

It was reported that the unspecified bd intravascular administration set experienced tubing expansion/ballooning/bulging.The following information was provided by the initial reporter: material #: unknown batch/ lot #: unknown mid-infusion, alaris pump began alarming "channel error." after opening the channel door an abnormal buldge of fluid was observed in the tubing.

Manufacturer Narrative

H6: investigation summary: two photos were returned by the customer.It was reported that an abnormal bulge of fluid was observed in the tubing.The photos were examined.The photos show the bulge in the pump segment, therefore the photos verify the complaint.A device history record review could not be performed because a model or lot number was not provided by the customer.The root cause of this failure was not identified as no product was returned.H3 other text : see h10.

• 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
• MDR Report Key: 11520349
• MDR Text Key: 268236027
• Report Number: 2243072-2021-00832
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K021475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• 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
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1