MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. ANGIOCATH BL 22GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number	381123
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
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 angiocath bl 22ga x 1.0in had air in the line.The following information was provided by the initial reporter: this is a report about air in line with the use of angiocath.According to the customer's report, when connecting to the a line, air entered.The customer is suspecting that there may be a crack on the catheter or the catheter hub.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-10-25 h6: investigation summary bd received a 22 gauge angiocath device from lot 9329998 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 no visual damage to the unit.Next, the unit was sent for a ct scan to identify if there were any micro-cracks that could not be identified.The ct scan confirmed that there was no damage to the sample that could have contributed to a possible leak or entryway for air.Based off of the visual inspection and ct scan the engineer could not verify the reported claim.Since no defects were found during inspection a definitive root cause could not be determined.H3 other text : see h10.
Event or Problem Description
It was reported that angiocath bl 22ga x 1.0in had air in the line.The following information was provided by the initial reporter: this is a report about air in line with the use of angiocath.According to the customer's report, when connecting to the a line, air entered.The customer is suspecting that there may be a crack on the catheter or the catheter hub.

• Brand Name: ANGIOCATH BL 22GA X 1.0IN
• 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: 12640273
• Report Number: 9610048-2021-00140
• Device Sequence Number: 4343988
• Product Code: FOZ
• UDI-Device Identifier: 00382903811236
• UDI-Public: 00382903811236
• 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): 12/30/2021

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: 11/30/2024
• Device Catalogue Number: 381123
• Device Lot Number: 9329998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2019
• 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