MAUDE Adverse Event Report: BECTON DICKINSON INSYTE AUTOG BC GLOBAL PNK 20GA X 1.16IN; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number 381034

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); Foreign Body Embolism (4439)

Event Date 10/12/2023

Event Type  Injury  

Event Description

Part of the cannula remained in the patient's vein.Part of the cannula remained in the patient's vein when the catheter was removed.Additional information: has there been any impact on the patient (serious injury, medical intervention, change in treatment required)? yes, additional tests carried out, medical intervention to come possibly (ansm declaration in progress on our part) could you provide detailed photos or videos of the product concerned? no better than the photo sent to ms.(b)(6), which i'm attaching as an attachment.No, no samples available.To answer your question "did the patient have to undergo surgery to remove the catheter?" to the best of my knowledge, not at the moment, but it is indeed envisaged by the patient.If we were aware of this surgical procedure, we would let you know.

Manufacturer Narrative

Patient problem code: e2008 - foreign body in patient.Patient problem code: f24 - insufficient information.Device problem code: a040103 - material fragmentation.(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Manufacturer Narrative

Investigation results: our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displayed two 20g insyte autoguard bc catheters with blood control technology laying side by side.One catheter exhibited evidence of use.What appeared to be blood residue was observed within the catheter tubing and adapter.It appeared that the actuator had been advanced through the septum.The other iv catheter exhibited no evidence of use, except that it had been removed from the needle.The length of the used catheter tubing appeared shorter than the unused catheter.The taper at the tip appeared to be missing.The reported issue was confirmed; however, the observable features on the submitted photograph did not contain enough information to identify a specific root cause.Without the physical sample, the tip of the damaged catheter could not be analyzed microscopically to help determine the root cause.This type of damage can occur if the tubing is severed by the needle during the insertion process or inadvertently cut during the removal process.During insertion, the instruction for use (ifu) warns, "do not re-insert the needle into the catheter tubing as damage may occur." during manufacturing, there is a 100% vision inspection that verifies the correct catheter length and lie distance between the catheter tip and needle bevel to help mitigate this type of damage.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.

Event Description

Additional response received: it states that "part of the cannula remained in the patient's vein when the catheter was removed." has this been confirmed by a diagnosis (x-ray, ct scan, ultrasound, other)? yes, song visualized on the radio.Where was the drip, which appendage, which side, which vessel? straight elbow crease.Please provide, if possible, any relevant information about the patient.Anxious patient, tense during the pose.

Manufacturer Narrative

Changed aa code to 'break' at regulatory compliance request to comply with their statistical selection process.

• Brand Name: INSYTE AUTOG BC GLOBAL PNK 20GA X 1.16IN
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18284984
• MDR Text Key: 329961159
• Report Number: 1710034-2023-01414
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903810345
• UDI-Public: (01)00382903810345
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 381034
• Device Lot Number: 3166522
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 12/20/2023; 12/20/2023
• Supplement Dates FDA Received: 01/10/2024; 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention