MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Model Number 382612

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Pain (1994)

Event Date 09/17/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: our quality engineer inspected the samples submitted for evaluation.Bd received seven 24g insyte autoguard bc winged units from lot number 1103236.Four of the seven units were returned sealed, and the rest were opened.A gross visual inspection found no damage to the components of the sealed units.The sealed units were tested for needle penetration force, catheter penetration force, and catheter drag force.All tested units were found to be within specification for all the tested categories.The opened units were inspected under a microscope for damage to the catheter tubing, catheter tip, or needle tip.No damage was found to the catheter tubing or needle tip on any of the opened units.However, one of the opened units was found to have an unacceptable catheter tip.Further inspection was performed on the identified defective unit.There were small traces of media found near the catheter tip and a loose strand of material was identified inside the catheter tubing.The loose material may have been skiving, however, as no damage was found on the rest of the catheter tubing, this cannot be confirmed.Likewise, no other media was observed inside the catheter so it cannot be determined with certainty if the unit was used.The reported issue was confirmed on the one opened unit regarding the catheter tip integrity.This was the physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect.There was no evidence to support or confirm a defect of the needle being dull or blunt and for threading difficulty.A device history record review showed no non-conformances associated with this issue during the production of this batch.The appropriate personnel have been notified and we appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: reported defect of threading difficult and needle dull/blunt was not confirmed but the defect of catheter tip integrity was confirmed.Root cause for catheter tip integrity was confirmed to be manufacturing related.

Event Description

It was reported that a bd insyte¿ autoguard¿ bc shielded iv catheter experienced foreign matter in the device cannula.The following information was provided by the initial reporter: i am getting a ton of feedback from my staff about needles seemingly being dull.I've probably had 10-20 reports over the last few weeks all from different staff and all from my best iv starters" "i am hearing that the dullness is experienced both during piercing of skin and when threading.But i seem to hear more about during the piercing of the skin.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12790875
• MDR Text Key: 280949630
• Report Number: 1710034-2021-00975
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903826125
• UDI-Public: 30382903826125
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110443
• 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: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2024
• Device Model Number: 382612
• Device Catalogue Number: 382612
• Device Lot Number: 1103236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2021
• 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