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

Model Number 382512

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/17/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: two photos were received by our quality team for evaluation.From the photos, the top web of a unit package and a view of the catheter adapter assembly with a foreign matter extending from the catheter tubing was observed.Visual observation reveals that the foreign matter on the tubing is hair, confirming the reported nonconformance.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.It is possible for human hair to get into the packaging during any point humans are in the same room as the material.The hair could come with the packaging raw material and be trapped inside of the top or bottom webbing role.The hair could also be introduced during packaging or manufacturing by accident or due to improper gowning.After investigation, no evidence to suggest that either gowning or inspection procedures were not followed.This scenario is likely.5s cleaning is performed by each shift to minimize the potential for introducing foreign matter to the product.The quality control plan, visual inspection, environmental monitoring, and gowning procedure are followed.The potential for the introduction of foreign matter does present itself in the clinical setting.As seen in the photo, the unit was opened, removed from the package, and manipulated.Therefore, the user practice cannot be ruled out as a possibility for the introduction of foreign matter.The origin of the foreign matter, introduction during manufacturing or user are both potentials.This incident has been added to our database of reported incidents.

Event Description

It was reported when using the bd insyte¿ autoguard¿ bc shielded iv catheter, the device experienced foreign matter in the device catheter.The following information was provided by the initial reporter.The customer stated:   wanted to let you know that i pulled a needle out of sterile packaging today, it was capped and appeared normal until i took off the cap and there was a black hair on the end of the needle.The hair is on the catheter.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 12665088
• MDR Text Key: 277398231
• Report Number: 1710034-2021-00896
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825128
• UDI-Public: 30382903825128
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial
• Report Date: 09/29/2021

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 Expiration Date: 03/31/2024
• Device Model Number: 382512
• Device Catalogue Number: 382512
• Device Lot Number: 1090022
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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