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

Model Number 381112

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 07/18/2022

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 bd angiocath¿ iv catheter was damaged.The following information was provided by the initial reporter: the catheter was damaged before use.

Event Description

It was reported that the bd angiocath¿ iv catheter was damaged.The following information was provided by the initial reporter: the catheter was damaged before use.

Manufacturer Narrative

H6: investigation summary bd received a 24 gauge angiocath device from lot 1181114 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit and observed that the needle had pierced through the catheter tubing.Therefore, based off the visual inspection the engineer was able to verify the reported defect.It was determined that this was likely a manufacturing defect caused by a misalignment between the needle and catheter during the catheter placement process.H3 other text : see h10.

• Brand Name: BD ANGIOCATH¿ IV CATHETER
• 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: 15225953
• MDR Text Key: 298072407
• Report Number: 9610048-2022-00092
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903811121
• UDI-Public: 30382903811121
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151698
• 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: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 381112
• Device Catalogue Number: 381112
• Device Lot Number: 1181114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2021
• 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