MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381212

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 01/31/2021

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that 30 bd insyte¿ iv catheters experienced no label or missing label information.The following information was provided by the initial reporter: there was no production date and expiration date on the package.

Event Description

It was reported that 30 bd insyte¿ iv catheters experienced no label or missing label information.The following information was provided by the initial reporter: there was no production date and expiration date on the package.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 4/5/2021.D.4.Medical device lot #: 0224296.D.4.Medical device expiration date: 7/31/2025.H.4.Device manufacture date: 8/11/2020.H.6.Investigation: four photos and nine samples were received by our quality team for evaluation.From the photos, a missing expiration date and batch number was observed on the unit packages.The samples were subjected to visual inspection to check on the variable print information.Missing variable print information was observed on all samples.The primary process packaging was reviewed.The non-conformance might have occurred at the variable printing station.At this station, the top web is first loaded and then fed to either the 1d or 2d variable station, and then the 1d or 2d printer control box is selected accordingly.The probable root cause could be that the top web was loaded to the 1d printer but the control 2d printer box was selected.This resulted in the missing variable print information no the top web.In addition, during changeover, the production technician likely failed to detect the missing variable print information on the top web resulting in the defective parts escaped to the next station.Device history record of packaged needle (pn) batch 0224296 catalogue number 381312 was reviewed.No quality notification was raised for similar nonconformance for the past 12 months.H3 other text : see h.10.

• Brand Name: BD INSYTE IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 11381786
• MDR Text Key: 233723590
• Report Number: 9610048-2021-00024
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K151698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/26/2021

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
• Device Operator: Other
• Device Catalogue Number: 381212
• Device Lot Number: 0224296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Manufacturer Received: 01/31/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 05/26/2021
• Supplement Dates FDA Received: 06/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1