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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 INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 393226
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/05/2018
Event Type  Injury  
Manufacturer Narrative
(b)(6). 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 bd venflon¿ pro safety peripheral safety iv catheter was inserted as usual. They used the venflon was subsequently found suitable for use of the procedure. After the ct scan they pulled out the venflon pro safety and discovered that the catheter was broken. They immediately scanned the patient and could see this piece of plastic in the patient's arm. Doctors from vascular surgery department were subsequently in correspondence and found no basis for further action. Found after use. No further information given at this time.
 
Manufacturer Narrative
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 returned to manufacture: yes.
 
Event Description
It was reported that the bd venflon pro safety peripheral safety iv catheter was inserted as usual. They used the venflon was subsequently found suitable for use of the procedure. After the ct scan they pulled out the venflon pro safety and discovered that the catheter was broken. They immediately scanned the patient and could see this piece of plastic in the patient's arm. Doctors from vascular surgery department were subsequently in correspondence and found no basis for further action. Found after use. No further information given at this time.
 
Manufacturer Narrative
Device returned to manufacture: yes.
 
Event Description
It was reported that the bd venflon pro safety peripheral safety iv catheter was inserted as usual. They used the venflon was subsequently found suitable for use of the procedure. After the ct scan they pulled out the venflon pro safety and discovered that the catheter was broken. They immediately scanned the patient and could see this piece of plastic in the patient's arm. Doctors from vascular surgery department were subsequently in correspondence and found no basis for further action. Found after use. No further information given at this time.
 
Manufacturer Narrative
Investigation summary: one actual sample, 8 representative samples and 2 photos were returned for the investigation of this complaint. Our quality engineer inspected the returned unit and confirmed the reported observation of a broken catheter. The manufacturing process was reviewed and there is no process in the manufacturing facilities that could have caused this nonconformance. The manufacturing process includes an automated vision inspection machine that will reject parts not meeting lie distance requirement. A broken catheter will automatically be rejected as the lie distance will be out of specification. A device history record review was also performed and showed no non-conformance's associated with this issue during the production of this batch. Therefore, source of the defect could not be determined. A clean cut was observed on the broken catheter. The broken catheter could have probably been cut by sharp object. There is no process in the manufacturing facilities that could have caused this nonconformance. Customer complaint trends are evaluated on a monthly basis. If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.
 
Event Description
It was reported that the bd venflon¿ pro safety peripheral safety iv catheter was inserted as usual. They used the venflon was subsequently found suitable for use of the procedure. After the ct scan they pulled out the venflon pro safety and discovered that the catheter was broken. They immediately scanned the patient and could see this piece of plastic in the patient's arm. Doctors from vascular surgery department were subsequently in correspondence and found no basis for further action. Found after use. No further information given at this time.
 
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Brand NameBD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key7654537
MDR Text Key112861945
Report Number8041187-2018-00216
Device Sequence Number1
Product Code FPA
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 08/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/28/2021
Device Catalogue Number393226
Device Lot Number8051116
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/02/2018 Patient Sequence Number: 1
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