MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INSYTE AUTOGUARD CATHETER

Catalog Number UNKNOWN

Device Problems Break (1069); Leak/Splash (1354); Retraction Problem (1536)

Patient Problems Bacterial Infection (1735); Needle Stick/Puncture (2462)

Event Date 05/10/2021

Event Type  Injury  

Manufacturer Narrative

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.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.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.Capa is not required at this time.

Event Description

It was reported that there was an infection on 20 occasions while using unspecified bd¿ insyte autoguard catheter.There were also reports of needle retraction issues on 5 occasions, safety mechanism failures on 5 occasions, needle stick injuries on 40 occasions, and defective/not working on 2 occasions.The following information was provided by the initial reporter: it was reported via post market survey that the clinician encountered bloodstream infection (e.G.Blood stream bacteraemia, sepsis) (20), phlebitis (130), infiltration / extravasation (145), catheter occlusion (267), needlestick injury - after use on patient - after safety mechanism activation (40), the catheter stuck to the safety device, (5), poor retraction of the security mechanism (5), and the device did not work (2).

• Brand Name: UNSPECIFIED BD INSYTE AUTOGUARD 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: 11943074
• MDR Text Key: 265889144
• Report Number: 2243072-2021-01607
• 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: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2021
• 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): Other