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

Catalog Number UNKNOWN

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

Patient Problems Bacterial Infection (1735); Phlebitis (2004); Skin Inflammation/ Irritation (4545)

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.Initial reporter first name: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that there was an infection on 100 occasions while using unspecified bd¿ pmcf insyte autoguard catheter.There were also reports of extravasation on 30 occasions, and chafing ulcers on 10 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) (10), phlebitis (30), infiltration / extravasation (30), catheter occlusion (30), and "chafing ulcers" (10).

Event Description

It was reported that there was an infection on 100 occasions while using unspecified bd¿ pmcf insyte autoguard catheter.There were also reports of extravasation on 30 occasions, and chafing ulcers on 10 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) (10), phlebitis (30), infiltration / extravasation (30), catheter occlusion (30), and "chafing ulcers" (10).

Manufacturer Narrative

H.6.Investigation: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Dhr could not be performed due to unknown lot#.H3 other text : see h.10.

• Brand Name: UNSPECIFIED BD PMCF INSYTE AUTOGUARD CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11942729
• MDR Text Key: 265888681
• Report Number: 2243072-2021-01599
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

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?: No
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other