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

Catalog Number 382523

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event is unknown; awareness date has been used for this field.There were multiple lot numbers reported to be involved.The information for each.Additional lot number is as follows: d4.Medical device lot #: 3117895.D4.Medical device expiration date: 30apr2026.H4.Device manufacture date: 01may2023.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology the catheter backed out of the vein.There was no report of patient impact.The following information was provided by the initial reporter: date of occurrences: (b)(6) 2023.Number of product affected: approximately 20 insytes.During this span of time with both 20 gauge and 22 gauge iv catheters.Description of what happened: multiple nursing staff reported that the iv catheter will not advance off of the needle once in the vein.Product # and lot #: 22ga (382523) lot# 3181571 lot# 3117895 20ga (382533) lot# 3142661 was the course of treatment altered?: yes, the patient had to be stuck more than once for an iv start.Any harm to the patient?: no, other than having to have a second iv start.We pulled all of the affected lots from our storeroom that i can send back if you would like.Add info received 3rd customer response: was there a delay of, or change in, the course of treatment due to the event?: delay in treatment due to more than 1 iv stick.What type of procedure is being performed?: iv start.What was the medication/fluid in use at the time of the event?: n/a.4th customer response the adhesion was broke before insertion with the iv attempts.The nurses state that the catheter won't thread into the vein and when they would push the button to retract the needle, the catheter would also retract from the vein with the needle.I am not able to give you specific dates/times as it was multiple nurses stating the same thing during those dates.

Manufacturer Narrative

Investigation results: our quality engineer inspected the representative samples submitted for evaluation.Bd received 1 sealed 22ga x 1.00in.Iag bc unit from lot number3117895.As the report states that the nurses had issues advancing the catheter, which caused the catheter to back out of the vein, a penetration and drag test was performed where the unit passed specifications.After testing, the catheter was advanced slightly off the needle to break tip adhesion and retracted.No resistance from the catheter was detected and all specifications were met so the reported defects could not be confirmed.The returned unit provided for evaluation met and performed per the required manufacturing specifications.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failures stated in your report.A device history record review showed no non-conformances associated with this issue during the production of this batch.Our quality engineer inspected the representative samples submitted for evaluation.Bd received 10 sealed 22ga x 1.00in.Iag bc units from lot number 3181571.Unfortunately, one of the ten units from lot number 3181571 was lost at the testing site.As the report states that the nurses had issues advancing the catheter, which caused the catheter to back out of the vein, a penetration and drag test was performed for 9 of the units where all units passed specifications.After testing, each catheter was advanced slightly off the needle to break tip adhesion and retracted.No resistance from the catheter was detected and all specifications were met so the reported defects could not be confirmed.The returned units provided for evaluation met and performed per the required manufacturing specifications.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failures stated in your report.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see manufacturer narrative below.

Event Description

No additional information.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 17932024
• MDR Text Key: 325626355
• Report Number: 1710034-2023-01195
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825233
• UDI-Public: (01)00382903825233
• 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,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 382523
• Device Lot Number: 3117895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2023
• 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