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

Model Number 381534

Device Problem Material Puncture/Hole (1504)

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

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: our quality engineer inspected the sample submitted for evaluation.Bd received one unit with all of its components present.Visual observation of the unit revealed a cut with a ¿v¿ shape which indicated the needle had pierced the tubing wall.The reported defect was confirmed.There were no traces of media present to indicate the unit had been used in venipuncture and no other damage was observed.This type of defect can occur during the manufacturing process, due to misalignment or bent tubing, or in the clinical setting, due to improper tip adhesion break.Since the unit was received out of its original packaging, bd could not determine a definite root cause.There is a 100 percent automated vision system inspection and a sampling plan implemented for tip spear and lie distance, which mitigates the occurrence of this defect.A device history record review could not be performed as the lot number is unknown.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd insyte¿ autoguard¿ shielded iv catheter experienced the needle piercing the catheter.The following information was provided by the initial reporter: have received a couple of these with deformed catheter.

• 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
• MDR Report Key: 12685714
• MDR Text Key: 278357943
• Report Number: 1710034-2021-00912
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903815341
• UDI-Public: 30382903815341
• Combination Product (y/n): N
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 381534
• Device Catalogue Number: 381534
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Date Manufacturer Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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