MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. NEXIVA DIFFUSICS 20G X 1.25 IN; INTERVASCULAR CATHETER

Catalog Number	383593
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
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 #: 0267605, medical device expiration date: 2023-09-30, device manufacture date: 2020-10-23.Medical device lot #: 0233540, medical device expiration date: 2023-08-31, device manufacture date: 2020-09-29.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 nexiva diffusics 20g x 1.25 in leaked.The following information was provided by the initial reporter: material no.: 383593, batch no.: 0267605, 0233540.It was reported 20g diffusics catheter is leaking out the back end of the catheter.Iv is still in place but piv is likely to be replaced.
Additional Manufacturer Narrative
H.6.Investigation: a complaint of leakage was received from the customer.A sample was returned to investigate the failure.During functional testing of the sample, no defects were observed on the product.The failure mode could not be replicated.A device history record review was completed by our quality engineer team for provided lot number 0233540 and 0267605.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.A root cause could not be determined as the defect could not be replicated.Complaint history review was completed.This is the first complaint for leakage at catheter junction on material 383593 & batch 0267605.This is the first complaint for leakage at catheter junction on material 383593 & batch 0233540.H3 other text : see h.10.
Event or Problem Description
It was reported that nexiva diffusics 20g x 1.25 in leaked.The following information was provided by the initial reporter: material no.: 383593 batch no.: 0267605, 0233540.It was reported 20g diffusics catheter is leaking out the back end of the catheter.Iv is still in place but piv is likely to be replaced.

• Brand Name: NEXIVA DIFFUSICS 20G X 1.25 IN
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11675763
• Report Number: 9610847-2021-00147
• Device Sequence Number: 3128184
• Product Code: FOZ
• UDI-Device Identifier: 00382903835935
• UDI-Public: 00382903835935
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173354
• 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): 05/11/2021

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: 383593
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1