MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ CATHETER

Catalog Number UNKNOWN

Device Problems Mechanical Problem (1384); Product Quality Problem (1506); Structural Problem (2506)

Patient Problem Extravasation (1842)

Event Date 04/11/2019

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.Investigation: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.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 during use of the unspecified bd¿ catheter the catheters were causing blowing veins.It was also reported that the catheters have burrs on the sheath and not being able to thread a wire through it without blowing the vein.The following information was provided by the initial reporter: per email: i hope this email finds the both of you doing well.I'm sending this s.O.S out to you as the cath lab staff is really struggling with the iv catheters.I talked this morning and he said to see if you could come out to work with them.Lots of issues.Blowing veins, not being able to thread a wire through it without blowing the vein, numerous sticks, etc.I brought the er director with me today to try to give them some pointers but they really think it's the bc part that is causing all of their issues.We have also noticed on the #20s that some have a little "burr" on the outside of the catheter sheath.I have one to show you and told the units to keep them if they find them.Amb surgery and er have both reported seeing these on the #20 gauges.Er has more luck getting #18s in than the #20s???.

• Brand Name: UNSPECIFIED BD¿ CATHETER
• 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: 8569387
• MDR Text Key: 148420267
• Report Number: 2243072-2019-00830
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2019
• 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