MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. NEXIVA 20GA X 1.25 IN DP WITH MAXZERO; INTRAVASCULAR CATHETER

Catalog Number	383577
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device expiration date: unknown.Initial reporter facility: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that nexiva 20ga x 1.25 in dp with maxzero catheter detached.The following information was provided by the initial reporter: material no.: 383577, batch no.: unknown.It was reported that needle detached from hub of the iv days after insertion.Per complaint details received: nexiva cannula came detached from hub of iv.They noticed days after insertion.They were not able to find the cannula after scan and studies.
Additional Manufacturer Narrative
H.6.Investigation: bd received a 20 gauge nexiva single port closed iv catheter system with a maxzero attachment from an unknown lot for evaluation.A review of the device history could not be performed as the reported lot was unknown.Our quality engineer visually inspected the returned unit and observed that there was no catheter tubing present over the wedge or within the nose of the adapter.The unit was then dissected and measured to see if there were any issues with the components.No issues were found with the components measurements.However, based off the visual inspection the engineer was able to verify the reported defect.Unfortunately, a definitive root cause could not be determined.The manufacturing facility has been notified of this incident and the findings.H3 other text : see h.10.
Event or Problem Description
It was reported that nexiva 20ga x 1.25 in dp with maxzero catheter detached.The following information was provided by the initial reporter: material no.: 383577, batch no.: unknown.It was reported that needle detached from hub of the iv days after insertion.Per complaint details received: nexiva cannula came detached from hub of iv.They noticed days after insertion.They were not able to find the cannula after scan and studies.

• Brand Name: NEXIVA 20GA X 1.25 IN DP WITH MAXZERO
• 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
• MDR Report Key: 11748188
• Report Number: 9610847-2021-00187
• Device Sequence Number: 11842047
• Product Code: FOZ
• UDI-Device Identifier: 00382903835775
• UDI-Public: 00382903835775
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• 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): 07/07/2021

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: 383577
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1