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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVENOUS CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVENOUS CATHETER Back to Search Results
Catalog Number 393224
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/07/2018
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the cannula packaging of the bd venflon¿ pro safety peripheral safety iv catheter "doesn't open sterile". Found during use. No reports of serious injury or medical intervention noted.
 
Event Description
It was reported that the cannula packaging of the bd venflon pro safety peripheral safety iv catheter "doesnt open sterile. " found during use. No reports of serious injury or medical intervention noted.
 
Manufacturer Narrative
Paper tear was observed on all the samples. Seal width of all samples passed the seal width specification of minimum 3mm. There are no unopened vps samples returned for the aseptic opening inspection as per ge-412. A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of package damaged/defective/other with lot #6301434 regarding (b)(4). Investigation conclusion: paper tear was observed on all the samples. Seal width of all samples passed the seal width specification of minimum 3mm. The probable root cause for paper tear could be due to the existing sealing gasket with an overall lower seal strength capability which leads to higher possibility of paper tear occurrence. (b)(4) was initiated for paper poor peel apart and this batch was produced before capa implementation date.
 
Event Description
It was reported that the cannula packaging of the bd venflon¿ pro safety peripheral safety iv catheter "doesn't open sterile. " found during use. No reports of serious injury or medical intervention noted.
 
Manufacturer Narrative
Correction: due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields. This supplemental emdr is filed to provide the following omitted fields: device single use?: no. Device returned to manufacturer: yes.
 
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Brand NameBD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
Type of DeviceINTRAVENOUS CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key7660337
MDR Text Key113308135
Report Number8041187-2018-00227
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup,Followup
Report Date 08/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2019
Device Catalogue Number393224
Device Lot Number6301434
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/03/2018 Patient Sequence Number: 1
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