MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L; CATHETER

Catalog Number 393224

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: one photo was received by our quality team for evaluation.Upon visual inspection of the photo, leakage between the flow control plug and the needle hub was observed.A device history record review found no non-conformances associated with this issue during production of this batch.Investigation conclusion: complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.Root cause description: based on the quality team's investigation, the root cause of the leakage could be due to the alignment issue during assembly of the flow control plug (fcp) adn the needle hub or it could be due to the user unintentionally pulling the fcp during needle withdrawal.However, as no sample was returned and it is not possible to confirm how the product has been used, the root cause cannot be determined.Rationale: the end user risk is acceptable per (b)(4).

Event Description

It was reported that venflon pro safety 20ga 1.1mm od 32mm l leaked.The following information was provided by the initial reporter: customer quotation: it leaks over immediately after puncture.We had only pulled the needle back once to where it was visible.Therefore, no in-out movements, which could explain the blood leaking out.Unfortunately, the batch number is not available.

• Brand Name: VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L
• Type of Device: 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 ; 8015296192
• MDR Report Key: 11083715
• MDR Text Key: 224861437
• Report Number: 8041187-2020-00873
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 12/07/2020

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: 393224
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/28/2020
• 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