MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. ANGIOCATH YEL 24GA X 0.75IN; INTERVASCULAR CATHETER

Catalog 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	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that angiocath yel 24ga x 0.75in had foreign matter on the needle.The following information was provided by the initial reporter: the customer reported about a black fm found onto the needle.
Event or Problem Description
It was reported that angiocath yel 24ga x 0.75in had foreign matter on the needle.The following information was provided by the initial reporter: the customer reported about a black fm found onto 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: 3/22/2021.H.6.Investigation: bd received a 24 gauge angiocath unit from an unknown lot for evaluation.A review of the device history record could not be performed as the reported lot was unknown.Our quality engineer visually inspected the returned unit and observed a piece of dark foreign matter (fm) on the needle hub.A piece of the fm was collected and sent for ftir analysis.The analysis showed that it was a piece of silicone.Silicone is used during the manufacturing process to assist with assembly and retraction.Silicone has been tested and found to not be hazardous to the user or patient.Based off the visual inspection the engineer was able to verify the reported defect.Unfortunately, a definitive root cause could not be determined.H3 other text : see h.10.

• Brand Name: ANGIOCATH YEL 24GA X 0.75IN
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 11632162
• Report Number: 9610048-2021-00051
• Device Sequence Number: 3496697
• Product Code: FOZ
• UDI-Device Identifier: 00382903811120
• UDI-Public: 00382903811120
• 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): 06/15/2021

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 Catalogue Number: 381112
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1