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

Model Number	381247
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	07/03/2021
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 20 bd insyte¿ iv catheter needles had foreign matter on them.The following information was provided by the initial reporter, translated from (b)(6) to english: "when open the package, there was foreign matter on the needle point.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-07-15.H6: investigation summary three photos and one unused representative sample were received by our quality team for evaluation.The photos were subjected to visual inspection to check for foreign matter.One white, loose foreign matter was observed on the cannula tip, however, the photos were too zoomed out for evaluation of the foreign matter appearance and type.The sample was subjected to visual inspection to check for foreign matter.No foreign matter was observed on the catheter and cannula.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.As the actual sample with foreign matter was not returned for foreign matter type identification through fourier transform infrared spectroscopy analysis, the actual foreign matter source could not be identified, and the root cause could not be established.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported that 20 bd insyte¿ iv catheter needles had foreign matter on them.The following information was provided by the initial reporter, translated from chinese to english: "when open the package, there was foreign matter on the needle point.".

• Brand Name: BD INSYTE¿ IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• MDR Report Key: 12255326
• Report Number: 8041187-2021-00668
• Device Sequence Number: 17052698
• Product Code: FOZ
• UDI-Device Identifier: 30382903812470
• UDI-Public: 30382903812470
• 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): 08/30/2021

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: 11/30/2025
• Device Model Number: 381247
• Device Catalogue Number: 381247
• Device Lot Number: 0325537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Received by Manufacturer: 07/03/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 09/02/2021
• 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