MAUDE Adverse Event Report: ANGIOCATH SPECIAL ORN 14GA X 5.25IN; INTRAVASCULAR CATHETER

Catalog Number	382269
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	03/03/2021
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 angiocath special orn 14ga x 5.25in had foreign matter.This occurred on 7 occasions.The following information was provided by the initial reporter: particles found in the angiocath package.Black fibers have been observed in manufacturing on the needle cover of angiocath.40 items were inspected of and on 7 items black fibers were found.The black fibers were analyzed using microscopic fourier transform infrared spectroscopy technique and sem/xrma at triskelion.The particles were determined to be cellulose.
Additional Manufacturer Narrative
H.6.Investigation: bd received two documents with photos and a ftir analysis submitted for evaluation.The reported issue was confirmed upon inspection of the provided documentation.The foreign matter was determined to be cellulose, which can be found in our packaging process.A review of the manufacturing area was performed and at the time, there were no potential sources of the foreign matter present.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.
Event or Problem Description
It was reported that angiocath special orn 14ga x 5.25in had foreign matter.This occurred on 7 occasions.The following information was provided by the initial reporter: particles found in the angiocath package.Black fibers have been observed in manufacturing on the needle cover of angiocath.40 items were inspected of and on 7 items black fibers were found.The black fibers were analyzed using microscopic fourier transform infrared spectroscopy technique and sem/xrma at triskelion.The particles were determined to be cellulose.

• Brand Name: ANGIOCATH SPECIAL ORN 14GA X 5.25IN
• Common Device Name: INTRAVASCULAR CATHETER
• MDR Report Key: 12451028
• Report Number: 9610847-2021-00428
• Device Sequence Number: 14348029
• Product Code: FOZ
• UDI-Device Identifier: 00382903822690
• UDI-Public: 00382903822690
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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: 01/31/2025
• Device Catalogue Number: 382269
• Device Lot Number: 0027108
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 10/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2020
• 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