MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. NEXIVA 22 GA X 1.75 IN SINGLE PORT; INTRAVASCULAR CATHETER

Model Number	383513
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 22 ga x 1.75 in single port needle would not retract all the way.This was discovered after use.The following information was provided by the initial reporter: material no.: 383513, batch no.: 8225978.It was reported that after inserting the catheter into the patient the needle would not retract all the way.The catheter had to be removed and a new one reinserted.
Event or Problem Description
It was reported that nexiva 22 ga x 1.75 in single port needle would not retract all the way.This was discovered after use.The following information was provided by the initial reporter: material no.: (b)(6) batch no.: 8225978.It was reported that after inserting the catheter into the patient the needle would not retract all the way.The catheter had to be removed and a new one reinserted.
Additional Manufacturer Narrative
H.6.Investigation: a device history record review was performed for provided lot number 8225978.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident and all inspections were found to be within specification.To aid in the investigation of this issue, one physical sample was returned to bd for evaluation by our quality engineer team.Unfortunately, as the sample was forwarded to the manufacturing facility for investigation, the sample became misplaced.If the sample is located, our quality team will complete a thorough sample investigation; however, at this time, we are unable to investigate the sample.

• Brand Name: NEXIVA 22 GA X 1.75 IN SINGLE PORT
• 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: 10002690
• Report Number: 9610847-2020-00143
• Device Sequence Number: 14151711
• Product Code: FOZ
• UDI-Device Identifier: 30382903835134
• UDI-Public: 30382903835134
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (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): 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 07/31/2021
• Device Model Number: 383513
• Device Catalogue Number: 383513
• Device Lot Number: 8225978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2020
• Initial Date Received by Manufacturer: 04/07/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other