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

Catalog Number	381112
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Initial reporter phone#: unknown.Initial reporter e-mail: 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 the bd angiocath¿ iv catheter leaked during use.The following information was provided by the initial reporter, translated from japanese: "this is a report about leakage occurring during the use of iagbc.During infusion with the use of iagbc, leakage occurred with leakage site unknown.".
Additional Manufacturer Narrative
H6: investigation summary: bd received a 24 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.However, due to difficulties returning samples to the manufacturing facility our quality engineer had to investigate the returned sample using high resolution photographs of the defect.The engineer was able to identify that the catheter was crumpled but there appeared to be no damage to the rest of the unit.Leakage testing was not able to be performed due to limitations and the site the sample was returned to.Therefore, based off the provided photos the engineer was unable to verify the reported defect of leakage or determine a definitive root cause.
Event or Problem Description
It was reported that the bd angiocath¿ iv catheter leaked during use.The following information was provided by the initial reporter, translated from japanese: "this is a report about leakage occurring during the use of iagbc.During infusion with the use of iagbc, leakage occurred with leakage site unknown.".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15921239
• Report Number: 9610048-2022-00162
• Device Sequence Number: 2492187
• Product Code: FOZ
• UDI-Device Identifier: 00382903811120
• UDI-Public: (01)00382903811120
• 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): 03/09/2023

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 Catalogue Number: 381112
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 03/20/2023
• 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