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

Model Number	381112
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that bd angiocath¿ iv catheter leaked.The following information was provided by the initial reporter: "this is a report about leakage occurring with the use of angiocath (381112).".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval?: yes.D9: returned to manufacturer on: 9/21/2021.H6: investigation: bd received a 24 gauge angiocath device from lot 0003442 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Unfortunately, due global health concerns the sample could not be returned to the original manufacturer for a visual inspection so the investigation was performed off of photographic evidence.Due to the lower resolution on the provided photo the engineer could not identify any visual defects that could have lead to a possible leak.Next, a ct scan was performed on the device to check for any possible damage or tears.The ct scan showed no damage or tear to the device that would have contributed to a possible leak.Therefore, the quality engineer was unable to verify the reported defect.Since no defects could be identified a definitive root cause could not be determined.
Event or Problem Description
It was reported that bd angiocath¿ iv catheter leaked.The following information was provided by the initial reporter: "this is a report about leakage occurring with the use of angiocath (381112).".

• Brand Name: BD ANGIOCATH¿ IV CATHETER
• Common Device Name: 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12507716
• Report Number: 9610048-2021-00130
• Device Sequence Number: 5146226
• Product Code: FOZ
• UDI-Device Identifier: 30382903811121
• UDI-Public: 30382903811121
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2024
• Device Model Number: 381112
• Device Catalogue Number: 381112
• Device Lot Number: 0003442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown