MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number	383530
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that customer received unit packaging that has a different device identification than the box of bd nexiva¿ closed iv catheter system.No patient impact reported.The following information was provided by the initial reporter: reported issue: issue as they packed a 24 g box with 22 g.The material number that was ordered was 383530.The material/lot number that was received was 383530 and the lot is 2062925.The package label on the outside of the box is labeled as 24g 0.56 in ivs.The product inside the box is material number 383532 and the lot number is 2062951.
Additional Manufacturer Narrative
H6: investigation summary: our quality engineer inspected the photographs provided for evaluation.Bd received two photographs.The photos display an opened 24g x 0.56in.Nexiva dispenser box for lot number 2062925.However, inside the box are multiple 22g x 1.00in.Nexiva units for lot number 2062951.The reported issue was confirmed.The device history review (dhr) was inspected to determine if the units were built on the same line.The dhr found that both lot numbers were manufactured at the same time however they were manufactured on different lines.A review of the production records from each lot showed no evidence that the product was never segregated.It could not be determined if the reported issue resulted from the manufacturing of the device, a mix of product at the distributor site or from the user environment.A device history record review showed no non-conformances associated with this issue during the production of this batch.
Event or Problem Description
It was reported that customer received unit packaging that has a different device identification than the box of bd nexiva¿ closed iv catheter system.No patient impact reported.The following information was provided by the initial reporter: reported issue: issue as they packed a 24 g box with 22 g.The material number that was ordered was 383530.The material/lot number that was received was 383530 and the lot is 2062925.The package label on the outside of the box is labeled as 24g 0.56 in ivs.The product inside the box is material number 383532 and the lot number is 2062951.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15174607
• Report Number: 1710034-2022-00415
• Device Sequence Number: 6347904
• Product Code: FOZ
• UDI-Device Identifier: 00382903835300
• UDI-Public: 00382903835300
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2022

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 Expiration Date: 02/28/2025
• Device Catalogue Number: 383530
• Device Lot Number: 2062925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown