MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD ANGIOCATH¿ IV CATHETER FOR SPECIAL PLACEMENT 14 GA X 3.25 IN; INTRAVASCULAR CATHETER

Model Number	382268
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).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 the bd angiocath¿ iv catheter for special placement 14 ga x 3.25 in had foreign matter on it prior to use.The following information was provided by the initial reporter: verbatim: it was reported that a foreign particulate was found on the sealed product.Event description per attached spreadsheet from distributor states: particulate¿.
Event or Problem Description
It was reported that the bd angiocath¿ iv catheter for special placement 14 ga x 3.25 in had foreign matter on it prior to use.The following information was provided by the initial reporter: verbatim: it was reported that a foreign particulate was found on the sealed product.Event description per attached spreadsheet from distributor states: particulate¿.
Additional Manufacturer Narrative
H.6.Investigation: a device history record review was performed for provided lot number 8346571.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident and all quality inspections were within specification.To further investigate this issue, one picture sample was provided for evaluation by our quality engineer team.Through examination of the picture, an embedded black dot was observed within the needle cover.Through the picture sample alone, our engineering team was unable to determine the exact size of the particulate.The workstations in which this product is manufactured are cleaned at the beginning of each shift to prevent defects such as this.Our quality team was unable to identify an exact cause for this incident, however, they will continue to monitor the production process for signs of this defect and other emerging trends.Based on the investigation conclusion the condition reported by the customer is confirmed.However, root cause to manufacturing process could not determined h3 other text : see h.10.

• Brand Name: BD ANGIOCATH¿ IV CATHETER FOR SPECIAL PLACEMENT 14 GA X 3.25 IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9733016
• Report Number: 9610847-2020-00055
• Device Sequence Number: 765507
• Product Code: FOZ
• UDI-Device Identifier: 30382903822684
• UDI-Public: 30382903822684
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2023
• Device Model Number: 382268
• Device Catalogue Number: 382268
• Device Lot Number: 8346571
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other