MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 20 G X .32 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER; INTERVASCULAR CATHETER

Catalog Number 393224

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.Results: a sample is not available for evaluation, however the customer provided four photos of the affected device for investigation.A photo inspection showed the customer's reported defect.A review of the device history record could not be performed as a lot number was not provided for this incident.Conclusion: although the customer's photos showed the reported defect, without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.(b)(4).

Event Description

It was reported that the safety shield of a 20 g x.32 mm bd venflon¿ pro safety peripheral safety iv catheter fell off when withdrawing the needle leaving the needle exposed.There was no report of injury or medical intervention.

• Brand Name: 20 G X .32 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
• Type of Device: INTERVASCULAR 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 ; 8015652845
• MDR Report Key: 6623440
• MDR Text Key: 77318292
• Report Number: 8041187-2017-00050
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: Yes
• 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?: No
• Date Manufacturer Received: 05/17/2017
• 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