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

Catalog Number 393224

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Information (3190)

Event Date 09/05/2017

Event Type  Injury  

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.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that there was a hole in the ¿plastic cannula¿ of the 20 g x.32 mm bd venflon¿ pro safety peripheral safety iv catheter, which allowed blood leakage and patients treatment plan to change.Additional attempts to place an iv line were unsuccessful.Patient¿s course of treatment was changed and the patient received a non-contrast ct (vs the originally planned ct with contrast).

Manufacturer Narrative

127 representative samples received.All 127 samples were subjected to visual inspection of the catheter tube and catheter adapter leak test.All the 127 samples pass the visual inspection of the catheter tube.No hole was observed on the catheter.Catheter of the representative sample.All the 127 samples pass the catheter adapter leak test the non-conformance of this complaint could not be determined.Complaint trend will be monitored.Dhr was reviewed.No qn issued for this vps batch.Manufacturing review: no abnormalities observed after reviewing preventive maintenance, calibration and equipment.

• Brand Name: 20 G X .32 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: 6898989
• MDR Text Key: 87591560
• Report Number: 8041187-2017-00106
• 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,health professional,o
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 10/30/2017

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: 393224
• Device Lot Number: 7110267
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2017
• Initial Date FDA Received: 09/27/2017
• Supplement Dates Manufacturer Received: 09/05/2017
• Supplement Dates FDA Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2017
• 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): Required Intervention