MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. INSYTE AUTOGUARD PNK 20GA X 1.16IN; CATHETER

Model Number 381834

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used as a default initial reporter fax number: (b)(6).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 that insyte autoguard pnk 20ga x 1.16in leaked.The following was reported by the initial reporter: "the sudden retraction of the safety system causes a huge problem in the venipuncture of patient, since the material of the catheter is too soft and does not advance after the safety mechanism is removed.It causes loss of access or extravasation of the medication after the puncture.There was an issue with extravasation of radioisotope medication, involving an mri exam, problems in the emergency puncture of patients in immediate care unit.".

Manufacturer Narrative

H.6.Investigation: a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 1085104, and no quality issues were found during production.Our quality engineer reviewed the provided photo but observed that the photo only showed the device inside of its sealed packaging.There was not enough evidence provided in the photo of the device to verify the reported defect.Since the defect could not be verified from the provided photo a definitive root cause could not be determined.H3 other text : see h.10.

Event Description

It was reported that insyte autoguard pnk 20ga x 1.16in leaked.The following was reported by the initial reporter: "the sudden retraction of the safety system causes a huge problem in the venipuncture of patient, since the material of the catheter is too soft and does not advance after the safety mechanism is removed.It causes loss of access or extravasation of the medication after the puncture.There was an issue with extravasation of radioisotope medication, involving an mri exam, problems in the emergency puncture of patients in immediate care unit.".

• Brand Name: INSYTE AUTOGUARD PNK 20GA X 1.16IN
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12418868
• MDR Text Key: 269747736
• Report Number: 9610048-2021-00126
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818341
• UDI-Public: 00382903818341
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2024
• Device Model Number: 381834
• Device Catalogue Number: 38183414
• Device Lot Number: 1085104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2021
• 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