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

Device Problems Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2021

Event Type  malfunction  

Event 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.

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 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.

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
• Type of Device: 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
• MDR Text Key: 283104823
• Report Number: 9610847-2021-00566
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835943
• UDI-Public: 30382903835943
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/23/2021
• Supplement Dates Manufacturer Received: 11/29/2021
• Supplement Dates FDA Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1