MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Retraction Problem (1536)

Patient Problems Venipuncture (2129); Wheal(s) (2241); Blood Loss (2597)

Event Date 03/03/2020

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 and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.  the lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Investigation conclusion: part number and lot number is unknown; a lot history review could not be performed.Root cause description: no root cause can be determined as no samples were received.Rationale: capa is not required at this time.

Event Description

It was reported that the unspecified bd¿ iv catheters were difficult to advance, blew veins, and threaded incorrectly during use.This caused blood leakage around the connection.Additionally, it was reported that the retraction button was difficult to activate, and the catheter was "more likely" to turn upside down while placing the dressing or flushing the line.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "it was reported that catheters are difficult to advance, blowing veins and sometimes threading incorrectly causing blood to leak around the connection.The wingtips cause pressure points at the tips and the retraction button is difficult to activate.Also the catheter is also more likely to turn upside down while placing dressing or flushing the line.".

• Brand Name: UNSPECIFIED BD IV CATHETER
• Type of Device: INTRAVASCULAR 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: 10231305
• MDR Text Key: 198611638
• Report Number: 2243072-2020-00996
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2020
• 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