MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD BC PRO WINGED 20GX1"; INTRAVASCULAR CATHETER

Catalog Number	382933
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.H6: investigation summary a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 3024408, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed six insyte autoguard packages.Five of these packages appeared to be without the proper label content.Therefore, based off the provided photo the engineer was able to verify the reported defect.It was determined that this was a manufacturing defect that occurred during the packaging process.Missing print can occur during the printing process due to dirty print heads, top web break, top web splice, and software issues.The manufacturing facility has been notified of this incident and the findings.A notification has been issued to all packaging personnel to raise awareness of this issue and ensure that each package is being inspected properly prior to release.H3 other text : see h.10.
Event or Problem Description
It was reported while using bd insyte autoguard bc pro winged 20gx1" the labels were missing information.This occurred 5 times.There was no report of patient impact.The following information was provided by the initial reporter: we have been notified of a second issue with the catheters from the same vendor lot.The issue was found during pack in our production area.5 catheter packs were observed without any text on them again if samples are required please let us know.Material details: bd.Mn: 1194416.Bn: 16347320.Vlot 3024408.56,000 delivered 04apr23.42,969 used in 13 fills.13,031 remaining.

• Brand Name: BD INSYTE AUTOGUARD BC PRO WINGED 20GX1"
• Common Device Name: INTRAVASCULAR CATHETER
• 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 ; 8448235433
• MDR Report Key: 17312946
• Report Number: 1710034-2023-00786
• Device Sequence Number: 4070217
• Product Code: FOZ
• UDI-Device Identifier: 00382903829330
• UDI-Public: (01)00382903829330
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2023

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: 01/31/2026
• Device Catalogue Number: 382933
• Device Lot Number: 3024408
• 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: 06/15/2023
• Initial Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2023
• 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