MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BAXTER LEUR LOCK EXTENSION SETS; CATHETER

Catalog Number UNKNOWN

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/02/2019

Event Type  malfunction  

Manufacturer Narrative

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.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field medical device expiration date: unknown.Device manufacture date: unknown.Bd was unable to perform a thorough investigation as no sample, lot, or material number were provided.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

Material no.: unknown, batch no.: unknown.It was reported that the unspecified baxter luer lock extension sets are not attaching sufficiently to the cathenas.The following information was provided by the initial reporter: per email: i am getting repeated reports of our baxter luer lock extension sets not attaching sufficiently to the cathenas.We are getting multiple disconnections (just pops off as if the spring is someone detaching) and people are struggling to connect the two.It has been noted with a few other brands of extension set as well.

• Brand Name: UNSPECIFIED BAXTER LEUR LOCK EXTENSION SETS
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8550665
• MDR Text Key: 147610616
• Report Number: 2243072-2019-00786
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other