MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE 24GA X 0.75IN; INTRAVASCULAR CATHETER

Catalog Number 38831114

Device Problem Material Deformation (2976)

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

Event Date 03/04/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the catheter tip was damaged on the bd insyte 24ga x 0.75in.The following information was provided by the initial reporter, translated from spanish to english: at the moment of puncturing the patient, it was felt a difficult to insert the catheter, and when it was removed it was observed that the catheter tip is damaged.

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, 9284824, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed that the catheter tip was bent.Based off the provided photo the engineer was able to verify the reported defect.However, during follow up attempts it was determined that the tip adhesion was not being broken prior to insertion and was likely the cause of the bent tip.H3 other text : see h10.

Event Description

It was reported that the catheter tip was damaged on the bd insyte 24ga x 0.75in.The following information was provided by the initial reporter, translated from spanish to english: at the moment of puncturing the patient, it was felt a difficult to insert the catheter, and when it was removed it was observed that the catheter tip is damaged.

• Brand Name: BD INSYTE 24GA X 0.75IN
• 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: 13844322
• MDR Text Key: 287575645
• Report Number: 9610048-2022-00024
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 38831114
• Device Lot Number: 9284824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2019
• 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