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

Catalog Number 38831414

Device Problem Defective Component (2292)

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

Event Date 02/06/2024

Event Type  malfunction  

Event Description

It was reported that bd insyte catheter becomes damaged.The following information was provided by the initial reporter, translated from spanish to english: i hereby report the novelty presented by the client with the product intravenous catheter no 20x1 1/4 unit as follows: "the product in the use is fired and makes lose the vein, it is necessary to re-canalize the patient".Add info received, apr 05 2024 has there been any harm to the patient/healthcare professional? yes, extravasation - tissue damage - multipunctures.¿ was there a need for medical and/or surgical intervention due to what happened (imaging tests, surgery, medication administration, etc.)? no ¿ has there been exposure of blood/chemotherapy to mucous membranes (eyes, nose and mouth) or skin? if yes, indicate whether the exposure was from the patient or the practitioner and what measures were taken (detail).No ¿ could you explain in detail how the procedure was carried out? 1.Hand washing is performed.2.The vein to be cannulated is located and the appropriate helmet is chosen.3.The tourniquet is placed 4-5 cm above the puncture point.4.It is massaged over the area to be punctured to promote venous filling.5.The limb is placed in decline to also favor venous filling.6.The antiseptic is applied to the area in circles from the inside out and allowed to dry.7.The gloves are put on.8.The catheter is held with the dominant hand and the protector is removed.9.The vein is fixed, making downward traction.10.The catheter is inserted with the bevel upwards at an angle of 15-30°, depending on the depth of the vein.11.It is punctured slightly below the point chosen for venipuncture and following the trajectory of the vein.12.Check that the catheter is in the vein for the appearance of blood return, loosen the tourniquet, gently remove the mandrel and simultaneously.Introduce the catheter.(in the cases reported, there is little blood return, and at the moment of extracting a little of the mandrel, the return is lost, for this reason new search for return is attempted and this is no longer obtained; for this.Reason it is decided to remove the entire mandrel and the catheter, showing the catheter already broken or, in its absence, the flowed tip, generating extravasation, multipuncture and tissue damage).

Manufacturer Narrative

Since the flashback is initially present and then lost, this may be a user technique issue rather than a device malfunction issue.The mdr filed conservatively for the catheter damage, but more than likely this is a use error result of the reinsertion attempt by the customer as described in the event details/problem and not a device malfunction.H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

• Brand Name: INSYTE
• Type of Device: 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: 19199044
• MDR Text Key: 341458081
• Report Number: 9610048-2024-00042
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903883141
• UDI-Public: (01)00382903883141
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2024

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: 38831414
• Device Lot Number: 3149061
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1