MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381523

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that an unspecified amount of bd insyte¿ autoguard¿ shielded iv catheters' packaging units were unsealed.The following information was provided by the initial reporter: "catheters seem to not be sterile as packaging was not sealed.They are not sealed and have a black lining on the packaging.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 20-sep-2023 h6: investigation summary bd received five unused 22 gauge insyte autoguard winged units from lot 3166523 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned units and observed black tape on the top of the packaging.Additionally, the seal was not fully formed where the black tape was present creating a sterility breach.Therefore, based off the visual inspection the engineer was able to verify the reported defect.It was determined that the black tape was preventing the packaging seal from forming completely.This was a manufacturing defect that was caused during the packaging process.The black tape was identified as splice tape and is used to hold two rolls of packaging together during the product process.It should have been removed by the packaging operator.H3 other text : see h10.

Event Description

It was reported that an unspecified amount of bd insyte¿ autoguard¿ shielded iv catheters' packaging units were unsealed.The following information was provided by the initial reporter: "catheters seem to not be sterile as packaging was not sealed.They are not sealed and have a black lining on the packaging.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17836266
• MDR Text Key: 324505560
• Report Number: 1710034-2023-01118
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903815234
• UDI-Public: 00382903815234
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381523
• Device Lot Number: 3166523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1