MAUDE Adverse Event Report: BD ANGIOCATH¿ IV CATHETER; INTRAVASCULAR CATHETER

Model Number	381112
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd angiocath¿ iv catheter tip was found damaged before use.The following information was provided by the initial reporter, translated from (b)(6) "according to the customer's report, the catheter tip was found to be damaged during the check before venipuncture.".
Additional Manufacturer Narrative
H.6.Investigation: bd received a 24 gauge angiocath device from lot 0003442 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 that the tip of the catheter was damaged.It was confirmed under a microscope that the tip of the catheter didn't have it uniform smooth shape but instead had a jagged edge and was missing some tip material.Based off the visual and microscopic inspection the engineer was able to verify the reported defect.It was determined that this was a manufacturing defect that occurred during the catheter tipping process.
Event or Problem Description
It was reported that the bd angiocath¿ iv catheter tip was found damaged before use.The following information was provided by the initial reporter, translated from japanese to english: "according to the customer's report, the catheter tip was found to be damaged during the check before venipuncture.".

• Brand Name: BD ANGIOCATH¿ IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• MDR Report Key: 12407010
• Report Number: 9610048-2021-00121
• Device Sequence Number: 5131293
• Product Code: FOZ
• UDI-Device Identifier: 30382903811121
• UDI-Public: 30382903811121
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2021

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: 12/31/2024
• Device Model Number: 381112
• Device Catalogue Number: 381112
• Device Lot Number: 0003442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 11/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2020
• 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