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

Catalog Number 393222

Device Problems Component Falling (1105); Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 10/03/2017

Event Type  malfunction  

Manufacturer Narrative

Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.Investigation summary: 2 photos were returned for investigation of this complaint.The first photo showing 2 used vps cannula (1 with plug white end cap, 1 without plug white end cap).The second photo shows 1 used vps cannula without plug white end cap.The returned photo shows that the used vps cannula is without white plug end cap.No abnormality based on dhr and manufacturing review.Conclusion: the non-conformance of this complaint could not be determined as there was no sample provided for the investigation of this complaint.

Event Description

It was reported after use of the 22 g x.25 mm bd venflon¿ pro safety peripheral safety iv catheter when withdrawing the needle the white end cap separates and falls off.This caused blood to leak from the device exposing a nurse¿s ungloved hands to the blood.There was no report of injury, exposure to mucosal membranes, or medical intervention.

• Brand Name: 22 G X .25 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
• Type of Device: INTRAVENOUS 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: 6977579
• MDR Text Key: 90993349
• Report Number: 8041187-2017-00136
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 393222
• Device Lot Number: 7110356
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2017
• Initial Date FDA Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2017
• 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