MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEOFLON PRO 24GA 0.7MM OD 19MM L; INTRAVASCULAR CATHETER

Catalog Number 391380

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Extravasation (1842)

Event Date 09/06/2020

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A device history record could not be completed as no lot number was received.Based on the quality team's investigation, the root cause of this incident cannot be determined.Based on the verbatim, the neoflon pro product seem to be functioning as intended.The neoflon pro uses bd instaflash needle technology which is designed with a notch on the needle to allow for rapid vessel confirmation at the point of insertion.After insertion, flashback will be observed in the catheter tubing.Investigation conclusion: unable to confirm the customer experience as no sample and no photo was returned.End user risk assessment: as per p-eura document, (b)(4), severity is limited (s2).Based on 12 months complaint trending, occurence, (total complaints in 12 months / 12 months sales volume) x 1,000,000, (6/3,065,300) x 1,000,000, 2 ipm which is remote (o2), the risk is acceptable per (b)(4).Root cause description: based on the verbatim, the neoflon pro product seem to be functioning as intended.The neoflon pro uses bd instaflashtm needle technology which is designed with a notch on the needle to allow for rapid vessel confirmation at point of insertion.After insertion, flashback will be observed in the catheter tubing.However, since there is no sample or photo returned for investigation, the root cause cannot be determined.Rationale: the root cause cannot be determined.Complaint trend would be monitored.

Event Description

It was reported that the neoflon pro 24 ga 0.7 mm od 19 mm l caused extravasation and infiltration during use.The following information was provided by the initial reporter: "the physician complaint is that since they start using neoflon pro, they have more venipuncture attempts, the product looks the same, but the technique of insertion is different.In the "old" neoflon you see blood on the catheter only when you start separate the catheter from the needle and in the neoflon pro you have blood visualization immediately and the catheter blood chamber is not filling completely as before and it take more time for the blood visualization in the blood chamber (only after separation vs the "old" neoflon that it happened immediately.The main issue as they say is the instaflush, they have more infiltration and extravasation.".

• Brand Name: NEOFLON PRO 24GA 0.7MM OD 19MM L
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10606165
• MDR Text Key: 213417602
• Report Number: 8041187-2020-00628
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 391380
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other