MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD ANGIOCATH CATHETER

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Sepsis (2067); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2021

Event Type  Death  

Manufacturer Narrative

Date of death: unknown.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.(b)(4).Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: 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.Root cause is undetermined.No sample, lot, or batch provided.

Event Description

It was reported that there was an infection on 41 occasions while using unspecified bd¿ angiocath catheter.The following information was provided by the initial reporter: material no: unknown, batch no: unknown.It was reported via post market survey that clinicians encountered occurrences of bloodstream infections (e.G.Blood stream bacteraemia, sepsis) (41), phlebitis (134), infiltration / extravasation (220), catheter occlusions (174), and primer failure (1).Additional information related to bloodstream infection: "wide-spectrum antibiotic therapy and long hospital" (528).Additional information related to bloodstream infection: "antibiotic therapy." (568).Additional information related to death following bloodstream infection: "a death by sepsis took place that could be related or not with the use of the catheter, because the sepsis could be due to another type of catheter or by surgery practiced to the patient.As i always say in this type of surveys the answers are rather approximate, as it is impossible to keep a complete track of each patient from the last years i¿ve been working." (568).

• Brand Name: UNSPECIFIED BD ANGIOCATH 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11813208
• MDR Text Key: 250236536
• Report Number: 2243072-2021-01416
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: UNKNOWN
• 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: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 04/13/2021
• 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): Death