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

Model Number	381123
Medical Device Problem Codes	Complete Blockage (1094); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported when using the bd angiocath¿ iv catheter the catheter kinked/bent during infusion and leakage.The following information was provided by the initial reporter.The customer stated: "after venipuncture, administration of the nutrient fluid was started, then leakage was observed; when removing the catheter and checking it, the hcp found that the catheter was bent.".
Additional Manufacturer Narrative
H.6.Investigation: bd received a 22 gauge angiocath device from an unknown lot for evaluation.A review of the device history record could not be performed as the reported lot was unknown and the lot could not be found on the returned unit.Our quality engineer visually inspected the returned unit and observed that the catheter was a little crooked.The sample was then sent for a ct scan to identify any damage to the unit and find any possible leak spots.The findings from the scan revealed no damage to the device that could have caused or contributed to a possible leak.Additionally, since the device was reported to have leaked the observed bend to the catheter had to have happened after use because if the device was bent before use it would not have been possible to successfully use the device.Therefore, the engineer was able to verify the reported issue of bent catheter but could not verify the reported leakage.Based off the previous observations it was unlikely that this was a manufacturing defect due to the device being bent after use.
Event or Problem Description
It was reported when using the bd angiocath¿ iv catheter the catheter kinked/bent during infusion and leakage.The following information was provided by the initial reporter.The customer stated: "after venipuncture, administration of the nutrient fluid was started, then leakage was observed; when removing the catheter and checking it, the hcp found that the catheter was bent.".

• 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: 12816729
• Report Number: 9610048-2021-00153
• Device Sequence Number: 11951270
• Product Code: FOZ
• UDI-Device Identifier: 30382903811237
• UDI-Public: 30382903811237
• 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): 02/01/2022

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: Health Professional
• Device Model Number: 381123
• Device Catalogue Number: 381123
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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