MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE AUTOGUARD; PERIPHERAL IV CATHETERS

Catalog Number	38184414
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd insyte autoguard winged catheter tip damaged.The following information was provided by the initial reporter, translated from portuguese to english: needle too far from the start of the catheter.Elderly patients with ballerina veins find catheter progression more challenging.Needle retracts too quickly, sometimes splashing blood distance from needle to start of catheter.Sensation of pushing the vein without cutting blunt tip.Bad cutting sensation painful for patient.Patients with more resistant skin needle guard too long, making it difficult to grip no problems in general, but not your preference -poor grip due to size.The catheter grinds very well and slides well safety trigger too fast, sometimes splashes or is triggered unintentionally reports some advantages and disadvantages somewhat blind catheter.I missed the blood return on the cannon difficult to grip.Needle slips out of the catheter if you don't hold the flap needle tighter in the polyurethane of the catheter used before, the bd's needle slips out very easily.Regarding the distance between the needle and the catheter, they report that many times when they notice the blood return through the instflash and are going to advance the catheter, the needle seems to have already transfixed the vessel and ends up losing the catheter.I took some photos to show that there was no significant difference or even that the competitor's would be a little further away, but the blood return in the cannon helps them to verify that it is still inside the vessel.Impact to patient: multiple punctures.
Additional Manufacturer Narrative
Correction: complaint reviewed by team.An incorrect failure was captured.This mdr is not needed.Cancel mdr.

• Brand Name: BD INSYTE AUTOGUARD
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora ; BR
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora ; BR
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20849125
• Report Number: 9610048-2024-00195
• Device Sequence Number: 19765550
• Product Code: FOZ
• UDI-Device Identifier: 00382903819232
• UDI-Public: (01)00382903819232
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 38184414
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown