MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 22 G X .25 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 393222

Device Problems Retraction Problem (1536); Difficult or Delayed Activation (2577); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2016

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.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6115342.A manufacturing review revealed no abnormalities with preventative maintenance, calibration, or equipment.Conclusion: 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 mechanism of a 22 g x.25 mm bd venflon¿ pro safety peripheral safety iv catheter with injection valve did not activate after use.There have been occasions when the staff had to manually pull the cover and users claim that there is a resistance when they want to completely pull out the needle.There were more than three separate incidents that occurred on (b)(6) 2016.There was no report of injury or medical interventions related to the safety mechanism failure.

• Brand Name: 22 G X .25 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
• 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 ; 8015652845
• MDR Report Key: 6053833
• MDR Text Key: 58712943
• Report Number: 8041187-2016-00075
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 393222
• Device Lot Number: 6115342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2016
• 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