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

Catalog Number UNKNOWN

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2020

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 in sections and the (b)(4) fda registration number has been used for the manufacture report number.Medical 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.(b)(4).

Event Description

It was reported that the unspecified bd¿ pumps iv tubing had a hole in it that caused leaking during use.The following information was provided by the initial reporter: "performed a full line change on infant using new iv tubing.Iv kept reading air in line, when rn looked there were no air bubbles seen, when tipped upside down line was leaking.Rn realized there was a small hole in the tubing that goes directly into the iv channel pump.".

Event Description

It was reported that the unspecified bd¿ pumps iv tubing had a hole in it that caused leaking during use.The following information was provided by the initial reporter: "performed a full line change on infant using new iv tubing.Iv kept reading air in line, when rn looked there were no air bubbles seen, when tipped upside down line was leaking.Rn realized there was a small hole in the tubing that goes directly into the iv channel pump.".

Manufacturer Narrative

H6: investigation summary no product or photo was returned by the customer.The customer complaint of component damage with leak 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.H3 other text : see h.10.

Event Description

It was reported that the unspecified bd¿ iv tubing had a hole in it that caused leaking during use.The following information was provided by the initial reporter: "performed a full line change on infant using new iv tubing.Iv kept reading air in line, when rn looked there were no air bubbles seen, when tipped upside down line was leaking.Rn realized there was a small hole in the tubing that goes directly into the iv channel pump.".

Manufacturer Narrative

The following fields were updated due to corrected information b5: describe event or problem: it was reported that the unspecified bd¿ iv tubing had a hole in it that caused leaking during use.The following information was provided by the initial reporter: "performed a full line change on infant using new iv tubing.Iv kept reading air in line, when rn looked there were no air bubbles seen, when tipped upside down line was leaking.Rn realized there was a small hole in the tubing that goes directly into the iv channel pump." d1: medical device brand name: unspecified bd¿ iv tubing h3 other text : see h.10.

• Brand Name: UNSPECIFIED BD IV TUBING
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11083989
• MDR Text Key: 225598745
• Report Number: 2243072-2020-02169
• 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,Followup
• Report Date: 01/07/2021

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: 10/21/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 12/29/2020; 01/07/2021
• Supplement Dates FDA Received: 01/01/2021; 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1