• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON MEDICAL (SINGAPORE) 22 G X .25 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 393222
Device Problem Fail-Safe Design Failure (1222)
Patient Problem Needle Stick/Puncture (2462)
Event Date 02/21/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(6). There is no 510(k) for this device as it is manufactured outside the us and not sold in the us. Results: the customer has indicated that samples are available for evaluation. However, prior to receiving samples the manufacturing site in (b)(4) completed a no sample investigation. As part of the investigation, a review of the device history record revealed no irregularities during the manufacture of the reported lot # 6203411. A manufacturing review revealed no abnormalities with preventative maintenance, calibration, or equipment that could have influenced the customer's reported issue. 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. In the event that samples are received, a new investigation will be completed and a supplemental report will be filed. (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 failed to function properly during a test in a clinical training department and the user suffered a needle stick injury. The needle did not come in contact with a patient, therefore the injury was from a clean needle. There was no report of medical intervention.
 
Manufacturer Narrative
Results: two used samples were returned for evaluation. Sample 1: a visual inspection revealed that the tether was detached from the needle hub. A microscopic inspection revealed that the heat stake post had no damage and measured within specification of 3. 5-4mm. The tether was observed to be deformed on the edges. The deformity was likely caused by stretching. Sample 2: a visual inspection revealed that the needle tip was not covered by the safety mechanism. A microscopic inspection revealed no damage to the v-clip. The catheter hub of this device was not returned for evaluation. A review of the device history record revealed no irregularities during the manufacture of the reported lot #6203411. A manufacturing review revealed no abnormalities with preventative maintenance, calibration, or equipment that could have influenced the customer's reported issue. Conclusion: although the returned samples exhibited defects, based on the device history record and manufacturing reviews, an absolute root cause for this incident cannot be determined. Remedial action required: although a root cause could not be determined, capa (b)(4) has been initiated to investigate needle stick injury related to this device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name22 G X .25 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
Type of DeviceINTRAVASCULAR 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 Key6398204
MDR Text Key70014082
Report Number8041187-2017-00026
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2019
Device Catalogue Number393222
Device Lot Number6203411
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/21/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number82497

Patient Treatment Data
Date Received: 03/12/2017 Patient Sequence Number: 1
-
-