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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON¿ IV CANNULA 20G X 1 IN. INTRAVASCULAR CATHETER

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BECTON DICKINSON BD VENFLON¿ IV CANNULA 20G X 1 IN. INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 391492
Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/21/2017
Event Type  Injury  
Manufacturer Narrative
Medical device expiration date: unknown. (b)(6). Device manufacture date: unknown. Investigation summary: bd (b)(6) received 1 photo from the customer facility for investigation. (b)(4) retention samples of lot# 17h2941m had been visually inspected, for any defect on catheter, all samples found in good condition. The complaint history for the lot# 17h2941m was reviewed and till date no complaint had been registered against the above lot for the defect ¿ damaged component /product. Dhr was reviewed for the product test. The entire routing test for reported lot found within the specification limit. No ncp for damaged component /product was reported and recorded in dhr in customer reported lot # 17h2941m. Log sheet ¿ station# (b)(4) picking problem is recorded in primary packaging process (ra assembly) during manufacturing of lot # ra68h311, ra68h312, ra68h313, ra68h301, ra68h302 & ra68h303. Stoppages ¿ the ptfe tube from batches (b)(4) are used in the manufacturing of lot # 17h2941m. No defect found in the ptfe tube for the batches consumed in the manufacturing lot# 17h2941m. Investigation conclusion: confirmed: bd was able to duplicate or confirm the customers¿ indicated failure mode customer returned photo showed the evidence of damaged component /product (catheter). Root cause description: the team reviewed the process controls of assembly process and packaging process. All process controls are in place. The team also checked the catheter pull force pull force of lot# 17h2941m & within the specification limit of minimum 15n. In description of complaint it is mentioned that at the time of dressing (tegaderm) the catheter was found broken. This indicates that there are chances that due to practice issue (during dressing) the catheter got broken / cut from the catheter adaptor. Also, some part of the ptfe tube can be seen in the photograph shared by the customer. Due to unavailability of defective sample further investigation could not be done. The team will monitor the defect during manufacturing and if any such incidence occur related to catheter damage or broken will take actions appropriately. The exact root cause is not identified.
 
Event Description
It was reported that during use, a bd venflon¿ iv cannula malfunctioned as the cannula broke from the hub of the shaft. The cannula remained in the vein. Medical intervention was required. The patient was transferred to (b)(6) hospital where a mri was performed. The cannula shaft was relocated during observation of mri but still remained in patient. Surgery was required and performed on the patient to remove the shaft.
 
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Brand NameBD VENFLON¿ IV CANNULA 20G X 1 IN.
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7060589
MDR Text Key92986053
Report Number2243072-2017-00223
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 10/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number391492
Device Lot Number17H2941M
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/29/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/27/2017 Patient Sequence Number: 1
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