MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER; INTRAVASCULAR CATHETER

Model Number	383594
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd nexiva¿ diffusics¿ closed iv catheter had "yellow tinting" and defective catheter tips.The following information was provided by the initial reporter: yellow tinting and bulging on tip of catheter.
Additional Manufacturer Narrative
"multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9324380, medical device expiration date: 2022-11-30 device manufacture date: 2019-12-27.Medical device lot #: 1015996, medical device expiration date: 2024-01-31, device manufacture date: 2021-03-03.Medical device lot #: 1078180, medical device expiration date: 2024-05-31, device manufacture date: 2021-06-15.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 the bd nexiva¿ diffusics¿ closed iv catheter had "yellow tinting" and defective catheter tips.The following information was provided by the initial reporter: yellow tinting and bulging on tip of catheter.
Additional Manufacturer Narrative
H.6.Investigation: bd was not able to confirm the customer¿s indicated failure mode because no samples or pictures were received to perform investigation.Dhr for this lot was reviewed and there are no internal rejects related to the reported issue by the customer.Root cause could not be determined.H3 other text : see h.10.

• Brand Name: BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER
• 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
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12864781
• Report Number: 9610847-2021-00566
• Device Sequence Number: 1377486
• Product Code: FOZ
• UDI-Device Identifier: 30382903835943
• UDI-Public: 30382903835943
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 11/29/2021

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 Model Number: 383594
• Device Catalogue Number: 383594
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown