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

Model Number	381123
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
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 that once inserted into the patient, the bd angiocath¿ iv catheter leaked iv fluid/blood.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "once inserted into the patient and bunged, the catheter will either leak iv fluid or blood from the patient.".
Additional Manufacturer Narrative
H6: investigation summary: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record could not be performed as the lot number was unknown.H3 other text : see h10.
Event or Problem Description
It was reported that once inserted into the patient, the bd angiocath¿ iv catheter leaked iv fluid/blood.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "once inserted into the patient and bunged, the catheter will either leak iv fluid or blood from the patient.".

• 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
• MDR Report Key: 11773944
• Report Number: 9610048-2021-00068
• Device Sequence Number: 3998208
• Product Code: FOZ
• UDI-Device Identifier: 30382903811237
• UDI-Public: 30382903811237
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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 Model Number: 381123
• Device Catalogue Number: 381123
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1