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

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Stretched (1601)

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

Event Date 02/21/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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, (b)(4) has been listed.And the franklin lakes 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 unspecified bd" tubing ballooned.The following information was provided by the initial reporter: material #: unknown batch/ lot #: unknown.It was reported that the alaris pump started alarming right away as the tubing began ballooning.Verbatim: the rn states the set was just placed into the alaris pump, but it started alarming right away and he saw the balloon.He took the tubing out, and the patient did not receive any medication from that tubing.

Event Description

It was reported that unspecified bd¿ tubing ballooned.The following information was provided by the initial reporter: material #: unknown batch/ lot #: unknown.It was reported that the alaris pump started alarming right away as the tubing began ballooning.Verbatim: the rn states the set was just placed into the alaris pump, but it started alarming right away and he saw the balloon.He took the tubing out, and the patient did not receive any medication from that tubing.

Manufacturer Narrative

H.6.Investigation: no product or photo was returned by the customer.The customer complaint of tubing defective / damaged 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 or 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 TUBING
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11517572
• MDR Text Key: 244380499
• Report Number: 2243072-2021-00828
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 03/19/2021

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: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1