MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM 18 GA 1.25 IN; INTERVASCULAR CATHETER

Model Number	383594
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/28/2020
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.(b)(4).
Event or Problem Description
It was reported that 40 bd nexiva¿ diffusics¿ closed iv catheter system 18 ga 1.25 in experienced foreign matter contamination which was noted prior to use.The following information was provided by the initial reporter: material no.: 383594 batch no.: 0052947 the user facility opened material 383594 and saw what they describe as " yellow debris near the green butterfly where the tube is".Nurse saw this when she opened the packaging.They have pulled the lot and are sequestering it as a precaution.
Event or Problem Description
It was reported that 40 bd nexiva¿ diffusics¿ closed iv catheter system 18 ga 1.25 in experienced foreign matter contamination which was noted prior to use.The following information was provided by the initial reporter: material no.: 383594 batch no.: 0052947.The user facility opened material 383594 and saw what they describe as " yellow debris near the green butterfly where the tube is".Nurse saw this when she opened the packaging.They have pulled the lot and are sequestering it as a precaution.
Additional Manufacturer Narrative
H6: investigation summary: a device history record review was performed for provided lot number 0052947 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, thirty representative samples were returned for evaluation by our quality engineer team along with picture samples.Through visual inspection of the returned samples, the yellow condition was observed on all of the samples received.The yellow condition is considered a normal part of the manufacturing process as it results from the laser hole drilling process.The yellow color observed is not foreign matter and is not considered a defect with the product.Our quality team will closely monitor the production process for issues related to the laser hole drilling process and any emerging trends.H3 other text : see h.10.

• Brand Name: BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM 18 GA 1.25 IN
• Common Device Name: INTERVASCULAR 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: 10557287
• Report Number: 9610847-2020-00289
• Device Sequence Number: 1241179
• Product Code: FOZ
• UDI-Device Identifier: 30382903835943
• UDI-Public: 30382903835943
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K173354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2020

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: 02/28/2023
• Device Model Number: 383594
• Device Catalogue Number: 383594
• Device Lot Number: 0052947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 11/20/2020
• 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