MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD; PERIPHERAL IV CATHETERS

Catalog Number 381834

Device Problems Defective Component (2292); Defective Device (2588)

Patient Problems Extravasation (1842); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/03/2023

Event Type  malfunction  

Event Description

It was reported that bd insyte autogaurd needle went through catheter during insertion.The following information was provided by the initial reporter, translated from spanish to english."a puncture is performed in the left forearm to cannulate the patient with catheter number 20, and a knot is seen under the skin, the catheter is immediately removed when the catheter is extracted, and a rupture of the catheter is seen on one side of the needle".Additional information received.- was the reported incident noted before, during or after use on the patient?: ans: the report was made after use.- has there been any harm to the patient/health care professional (detail)?: ans: the patient presents mechanical phlebitis, without evolution and complication.- was there a need for medical and/or surgical intervention due to what happened (imaging tests, surgery, administration of medication, etc.)?: (detail) ans: no surgical intervention was needed.- was there exposure of blood/chemotherapy to mucous membranes (eyes, nose and mouth) or skin?: if yes, please state whether the exposure was the patient's or the practitioner's and what measures were taken.(detail).Ans: no exposure to fluids.- what medication was being administered?: ans: the medication was not administered, since in the first puncture the non-serious adverse event occurred.

Manufacturer Narrative

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

Additional information: 1) does the needle go through the catheter wall? ans - the needle went through the catheter wall at the end of the procedure.2) did the catheter and needle remain intact during the intravenous insertion process? ans - before inserting the catheter, the catheter was found to be intact upon inspection.3) did the reported event define a venous rupture ans - there was an extravasation of the vein.

Manufacturer Narrative

Investigation results: the complaint that the catheter was punctured was confirmed and the cause was likely associated with use.Two photographs were provided for investigation, which showed a 20ga insyte autoguard unit.One photo showed what appeared to be a breach in the catheter tubing near the tip.The catheter was likely damaged by the needle.As the damage was reportedly detected under the skin, the catheter was likely damaged during the insertion process.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no issues with the manufacturing process.This defect may occur during manufacturing.While the adapter is loaded onto the grip assembly, the adapter is placed to pre-seat tooling.Incorrect equipment settings may cause the catheter to get damaged or the needle to spear through the catheter tubing.A 100% vision system, challenge sample, and visual inspections per quality control plans are in place to mitigate the occurrence of this defect.Another possibility is that this occurred during client use.This defect may occur if the needle is advanced at the wrong angle or if the needle is moved up and down the catheter tubing while the tubing is in the vein.Ifu states to hold the needle assembly stationary after insertion and during catheter advance.This defect may also occur during tip adhesion break or needle cover removal.Normally if this defect was a result of manufacturing, the needle would be spearing through the catheter upon opening of the package, but since the complaint states that the defect occurred during use, this was most likely due to an application error.The complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: PERIPHERAL IV CATHETERS
• 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: 18023293
• MDR Text Key: 326851128
• Report Number: 1710034-2023-01233
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818341
• UDI-Public: (01)00382903818341
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381834
• Device Lot Number: 3010271
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2023
• 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