MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD ANGIOCATH¿ IV CATHETER; INTRAVASCULAR CATHETER

Model Number	382277
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.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 while using bd angiocath¿ iv catheter the catheter separated from the hub.There was no report of patient impact.The following information was provided by the initial reporter: it was stated by the customer that it was discovered that the elongated sheath can be disconnected from the hub component of the sheath.The hub component was unknowingly left insitu whilst cannulation occurred.This resulted in a partial cannulation to enable attachment of a bung at the catheter end.A fully advanced catheter would cover the hub and the cannula couldn¿t be accessed to be capped off, resulting in bleed back.
Event or Problem Description
It was reported while using bd angiocath¿ iv catheter the catheter separated from the hub.There was no report of patient impact.The following information was provided by the initial reporter: it was stated by the customer that it was discovered that the elongated sheath can be disconnected from the hub component of the sheath.The hub component was unknowingly left insitu whilst cannulation occurred.This resulted in a partial cannulation to enable attachment of a bung at the catheter end.A fully advanced catheter would cover the hub and the cannula couldn¿t be accessed to be capped off, resulting in bleed back.
Additional Manufacturer Narrative
H6: investigation summary : our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of shield damaged / defective was confirmed upon inspection of the photo.However, bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.No dhr review was performed since the user did not provide the batch reported.

• Brand Name: BD ANGIOCATH¿ IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16127938
• Report Number: 1710034-2022-00905
• Device Sequence Number: 7636638
• Product Code: FOZ
• UDI-Device Identifier: 30382903822776
• UDI-Public: (01)30382903822776
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K013800
• 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): 02/17/2023

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: Health Professional
• Device Model Number: 382277
• Device Catalogue Number: 382277
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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