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

Catalog Number 382512

Device Problem Material Puncture/Hole (1504)

Patient Problems Perforation of Vessels (2135); Skin Inflammation/ Irritation (4545); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2023

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the needle pierced through the bd insyte¿ autoguard¿ bc shielded iv catheter while advancing it during use.The following information was provided by the initial reporter: "customer reported bizarre product failure.The catheter failed.In addition to the bizarre failure, hcp reports a more common issue of the needle being dull.The incident with the catheter in question went as follows.Tech set up for iv catheter as normal, stuck the patient, and upon advancement of the catheter he noticed that it was not advancing as easily as it normally does and with increased tension in comparison to people with thicker/scarred skin.After attempting to advance the catheter the tech noticed the vein had infiltrated and the surrounding area had begun to swell so he removed the iv needle and catheter together without forcing the needle back through.Upon removal the catheter and needle exited the skin with the catheter sheared off the reaming part of the needle that was in after trying to advance.He did not try pushing the needle back into the catheter before removing so it shouldn¿t have punctured the catheter.A few of the following patients that had iv attempts with the same set of iv catheters complained that the needle felt dull (more so than previous experiences with blood draws and ivs).The nuclear medicine tech had to attempt iv sticks with this lot numerous times with each patient.After ordering a different product none of these issues continued.".

Event Description

It was reported that the needle pierced through the bd insyte¿ autoguard¿ bc shielded iv catheter while advancing it during use.The following information was provided by the initial reporter: "customer reported bizarre product failure.The catheter failed.In addition to the bizarre failure, hcp reports a more common issue of the needle being dull.The incident with the catheter in question went as follows.Tech set up for iv catheter as normal, stuck the patient, and upon advancement of the catheter he noticed that it was not advancing as easily as it normally does and with increased tension in comparison to people with thicker/scarred skin.After attempting to advance the catheter the tech noticed the vein had infiltrated and the surrounding area had begun to swell so he removed the iv needle and catheter together without forcing the needle back through.Upon removal the catheter and needle exited the skin with the catheter sheared off the reaming part of the needle that was in after trying to advance.He did not try pushing the needle back into the catheter before removing so it shouldn¿t have punctured the catheter.A few of the following patients that had iv attempts with the same set of iv catheters complained that the needle felt dull (more so than previous experiences with blood draws and ivs).The nuclear medicine tech had to attempt iv sticks with this lot numerous times with each patient.After ordering a different product none of these issues continued.".

Manufacturer Narrative

The following fields were updated due to corrections: h.6.Imdrf annex e grid: e1720, e0511.H.6.Imdrf annex f grid: f11.

Event Description

No additional information.

Manufacturer Narrative

Our quality engineer inspected the samples and photograph submitted for evaluation.Bd received 40 (39 sealed and 1 used) 24g x 0.75in.Insyte autoguard units from lot number 2284601.Additionally, one photo was provided for investigation which is representative of what was returned and does not provide any additional evidence that isn¿t already covered by the physical sample evaluation.A gross visual inspection of the returned units found that needle was spearing through the catheter on the used unit.Since the catheter exhibited what appeared to be blood residue throughout the tubing, the damage likely occurred during the insertion process.None of the sealed samples showed any damage or the needle puncturing the catheter tubing.A functional test to simulate needle tip penetration, catheter tip penetration, and catheter drag revealed the measured force of two units exceeded the needle tip and catheter tip penetration specifications, which confirmed a dull needle and catheter tip integrity issue.The report of threading difficulty was not confirmed as the catheter drag measurements were within specification.A needle that is dull or blunt may occur in the manufacturing setting due to improper offload, operator handling, station misalignment, incorrect equipment settings, or gripper damage.It is also possible that the damage may come from the raw material.The raw material needle subassembly inspection records were verified to have been performed and completed with no quality issues or process deviations.Operators perform penetration testing per the sampling and quality plans to mitigate the occurrence of this defect.Damage to the catheter tip may occur due to a worn mandrel, dirty die, or incorrect process parameters (temperature and/or tipping force).Mandrel verification, software validation, supplier qualification of die, and catheter tip inspections are all in place to mitigate the risk from this type of defect.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.We regret any inconveniences this incident may have caused you and your facility.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16640057
• MDR Text Key: 312319620
• Report Number: 1710034-2023-00333
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825127
• UDI-Public: 00382903825127
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201075
• 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,Followup,Followup
• Report Date: 07/23/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 382512
• Device Lot Number: 2284601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 05/15/2023; 05/18/2023
• Supplement Dates FDA Received: 05/30/2023; 07/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2022
• 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