MAUDE Adverse Event Report: BECTON DICKINSON BD NEOFLON¿ PRO SAFETY ARTERIAL CANNULA

Catalog Number 380074

Device Problem Free or Unrestricted Flow (2945)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/09/2022

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.The reported lot# 1110343 was not found for the reported catalog# 380074.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd neoflon¿ pro safety arterial cannula's flow control valve was defective and allowed blood through during use.The following information was provided by the initial reporter, translated from (b)(6): "automatic locking system not working.Blood comes out despite the operator closing the red lever.Unsafe and not very handy device".

Event Description

It was reported that the bd neoflon¿ pro safety arterial cannula's flow control valve was defective and allowed blood through during use.The following information was provided by the initial reporter, translated from italian: "automatic locking system not working.Blood comes out despite the operator closing the red lever.Unsafe and not very handy device".

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval yes.D9: returned to manufacturer on: 12-jun-2022.Investigation summary: a device history review was conducted for lot number 1110343.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally a sample was submitted to aid in our investigation.Leakage testing of the returned unit found the device to be free of leakage and operating normally.Torsion testing similarly was unable to identify any obstructions to complete activation.Both sets of tests were repeated an additional 4 times on retention samples, and all results were replicated.Based on these tests our engineers were not able to associate the root cause with the manufacturing process.The issue maybe related to a partial activation during use, but this cannot be confirmed by functional testing alone.

• Brand Name: BD NEOFLON¿ PRO SAFETY ARTERIAL CANNULA
• Type of Device: ARTERIAL CANNULA
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14315972
• MDR Text Key: 291217617
• Report Number: 2243072-2022-00639
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/12/2022

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 Catalogue Number: 380074
• Device Lot Number: SEE SECTION H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 05/07/2022
• Supplement Dates Manufacturer Received: 06/12/2022
• Supplement Dates FDA Received: 07/07/2022
• 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