MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER

Model Number 383323

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 08/05/2021

Event Type  Injury  

Manufacturer Narrative

Investigation summary: our quality engineer inspected the two photos and video submitted for evaluation.The reported issue was not confirmed upon inspection of the photos and video, since no failure could be observed in the provided material.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.A device history record review showed no non-conformance's associated with this issue during the production of this batch.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.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 safety mechanism on the bd saf-t-intima¿ iv catheter safety system failed after activation, allowing the needle to poke through and cause a dirty needle stick.The following information was provided by the initial reporter, translated from chinese to english: "after the nurse activated and removed the safety device, the needle poked out of the safety device and punctured the nurse, and the patient was a hepatitis b patient" "at that time, the product with needlestick injury had already been handled by the customer.As the customer was an emergency water flow, the monthly usage of about 2000 yema was about, and there were many patients punctured daily.The withdrawn needlepoint protection device was bent in the sharp instrument cylinder, and the needle core was re-pierced, which caused the hidden danger of needlestick injury.After the completion of the puncture, due to the limitation of the emergency water environment, it is often impossible to drop the protective device into the sharp cylinder in the first time, and our multi-point design end cannot be felt even when wearing gloves.".

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 12421956
• MDR Text Key: 270499393
• Report Number: 9610847-2021-00416
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833239
• UDI-Public: 30382903833239
• Combination Product (y/n): N
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: 383323
• Device Catalogue Number: 383323
• Device Lot Number: 0233515
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2021
• Initial Date FDA Received: 09/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2020
• 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
• Patient Outcome(s): Required Intervention