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

Catalog Number	383594
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
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 #: 0329097, medical device expiration date: 2023-12-31, device manufacture date: (b)(6) 2021.Medical device lot #: 0294778, medical device expiration date: 2023-10-31, device manufacture date: (b)(6) 2020.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 18g x 1.25 in had foreign matter and the catheter tip was broken.The following information was provided by the initial reporter: material no: 383594 batch no: 0329097 and 0294778.It was reported brown coloring around holes on diffusics catheter, tip of catheter was brittle and broke off.
Event or Problem Description
It was reported that nexiva diffusics 18g x 1.25 in had foreign matter and the catheter tip was broken.The following information was provided by the initial reporter: material no: 383594 batch no: 0329097 and 0294778.It was reported brown coloring around holes on diffusics catheter, tip of catheter was brittle and broke off.
Additional Manufacturer Narrative
H.6.Investigation: a complaint of discoloration around holes on tubing, catheter tip integrity, was received from the customer.312 representative unopened samples for lot 0329097 and 16 representative unopened samples for lot 0294778 were received for evaluation.When inspecting samples per procedure no discoloration could be seen on the tubing.The 100% samples were activated in order to simulate the use of the catheter, catheter integrity was acceptable and no visual damages on the catheter after activation were detected.A device history record review was completed by our quality engineer team for provided lot number 0329097 and 0294778.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.It has been confirmed that the reported condition is caused by the heat from the laser used to manufacture the diffusics product.Some brown discoloration is considered as acceptable.Per drawing specification and correct inspections methods all the evaluated samples are defined as acceptable.

• Brand Name: NEXIVA DIFFUSICS 18G X 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: 11691076
• Report Number: 9610847-2021-00168
• Device Sequence Number: 14361214
• Product Code: FOZ
• UDI-Device Identifier: 00382903835942
• UDI-Public: 00382903835942
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/29/2021

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 Catalogue Number: 383594
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1