MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ IV CATHETER 24GA; INTRAVASCULAR CATHETER

Catalog Number 38831114

Device Problem Material Perforation (2205)

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

Event Date 11/09/2022

Event Type  malfunction  

Manufacturer Narrative

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¿ iv catheter 24ga the needle pierced the catheter.There was no report of patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: "the latex in its terminal part is crooked, which does not allow an adequate channeling, generating discomfort for the patient because it is necessary to repeat the procedure" (evidence is attached), clarifying that we send original boxes from our warehouses in the orders for this it is not possible to evidence this novelty in the product.".

Manufacturer Narrative

H6: investigation summary 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, 2006902, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed that the needle had pierced through the catheter tubing.Therefore, based off the provided photo the engineer was able to verify the reported defect.Unfortunately, without a physical sample available for testing a definitive root cause could not be determined but the engineer identified that this type of defect could occur during the catheter placement process if there was a misalignment between the needle and the catheter when set.The manufacturing facility has been notified of this incident and the findings.H3 other text : see h10.

Event Description

It was reported while using bd insyte¿ iv catheter 24ga the needle pierced the catheter.There was no report of patient impact.The following information was provided by the initial reporter, translated from spanish to english: "the latex in its terminal part is crooked, which does not allow an adequate channeling, generating discomfort for the patient because it is necessary to repeat the procedure" (evidence is attached), clarifying that we send original boxes from our warehouses in the orders for this it is not possible to evidence this novelty in the product.".

• Brand Name: BD INSYTE¿ IV CATHETER 24GA
• Type of Device: INTRAVASCULAR 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15941641
• MDR Text Key: 308257642
• Report Number: 9610048-2022-00163
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903883110
• UDI-Public: (01)00382903883110
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 38831114
• Device Lot Number: 2006902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• 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