MAUDE Adverse Event Report: BD INSYTE-W¿ IV CATHETER WITH WINGS 22GA 1.00IN; INTRAVASCULAR CATHETER

Model Number	381323
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	07/13/2021
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 when using the bd insyte-w¿ iv catheter with wings 22ga 1.00in there was foreign matter on device cannula/needle/catheter.The following information was provided by the initial reporter.The customer stated: "the indwelling needle was replaced after a hairy, flock-like foreign body was found at the tip of the indwelling needle while administering infusion to the patient.".
Event or Problem Description
It was reported when using the bd insyte-w¿ iv catheter with wings 22ga 1.00in there was foreign matter on device cannula/needle/catheter.The following information was provided by the initial reporter.The customer stated: "the indwelling needle was replaced after a hairy, flock-like foreign body was found at the tip of the indwelling needle while administering infusion to the patient.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes d10: returned to manufacturer on: 2021-09-03 investigation summary: one sample was received by our quality team for evaluation.The sample was subjected to visual inspection to check for foreign matter.No foreign matter was observed on the cannula tip and catheter.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD INSYTE-W¿ IV CATHETER WITH WINGS 22GA 1.00IN
• Common Device Name: INTRAVASCULAR CATHETER
• MDR Report Key: 12454373
• Report Number: 8041187-2021-00824
• Device Sequence Number: 1179780
• Product Code: FOZ
• UDI-Device Identifier: 30382903813231
• UDI-Public: 30382903813231
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/14/2021

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: 04/30/2025
• Device Model Number: 381323
• Device Catalogue Number: 381323
• Device Lot Number: 0114872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 11/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2020
• 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