MAUDE Adverse Event Report: BD ANGIOCATH IV CATHETER 24GA 0.75IN; INTRAVASCULAR CATHETER

Model Number	381112
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 that bd angiocath iv catheter 24ga 0.75in contained foreign matter.The following information was provided by the initial reporter: "according to the customer's report, the hcp felt something different upon puncture and pulled out the needle, and then found an fm around the center of the needle.".
Event or Problem Description
It was reported that bd angiocath iv catheter 24ga 0.75in contained foreign matter.The following information was provided by the initial reporter: ".According to the customer's report, the hcp felt something different upon puncture and pulled out the needle, and then found an fm around the center of the needle.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 5/27/2021.H.6.Investigation: bd received a 24 gauge angiocath device from lot 9157626 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 a piece of foreign matter (fm) on the device's needle.A piece of the fm was collected and sent for ftir analysis.Ftir testing determined that the fm was most likely epoxy or glue mixed with silicone.Epoxy and silicone were used during the manufacturing facility.Epoxy was used to attach the cannula to the hub and silicone was used to assist with the assembly of the device and aid with retraction.Based off the visual inspection and ftir testing the engineer was able to verify the reported defect.Unfortunately, a definitive root cause could not be determined.

• Brand Name: BD ANGIOCATH IV CATHETER 24GA 0.75IN
• Common Device Name: INTRAVASCULAR CATHETER
• MDR Report Key: 11971471
• Report Number: 9610048-2021-00092
• Device Sequence Number: 19888478
• 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): 08/05/2021

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: 05/31/2024
• Device Model Number: 381112
• Device Catalogue Number: 381112
• Device Lot Number: 9157626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 08/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2019
• 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