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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON¿ 2 PRO SAFETY SHIELDED IV CATHETER INTERVASCULAR CATHETER

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BECTON DICKINSON BD VENFLON¿ 2 PRO SAFETY SHIELDED IV CATHETER INTERVASCULAR CATHETER Back to Search Results
Catalog Number 391451
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Abscess (1690); Fever (1858); Infiltration into Tissue (1931); Inflammation (1932); Pneumonia (2011); Reaction (2414)
Event Date 03/18/2018
Event Type  Injury  
Manufacturer Narrative
The manufacturing location for this product is bawal, india. This site is not registered with the fda. Therefore, (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. (b)(6). There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 17d2841k, medical device expiration date: unknown , device manufacture date: unknown. Medical device lot #: 17c1041g, medical device expiration date: 2022-02-28, device manufacture date: 2017-08-02. 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 after use of a bd venflon¿ 2 pro safety shielded iv catheter the patient experienced a strong inflammatory reaction (a fever has occurred, symptoms of a local inflammation of the forearm of the right hand with extensive infiltration above the elbow area). The removal of the puncture and local treatment of the compresses were ordered and antibiotics were included. Currently perceptible organized abscesses. Surgically consulted, the abscess was notched without obtaining pus. The parameters of inflammation and fever tend to increase. Currently, the patient's condition requires hospitalization. Then the patient had left-sided pneumonia.
 
Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, 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 after use of a bd venflon¿ 2 pro safety shielded iv catheter the patient experienced a strong inflammatory reaction (a fever has occurred, symptoms of a local inflammation of the forearm of the right hand with extensive infiltration above the elbow area). The removal of the puncture and local treatment of the compresses were ordered and antibiotics were included. Currently perceptible organized abscesses. Surgically consulted, the abscess was notched without obtaining pus. The parameters of inflammation and fever tend to increase. Currently, the patient's condition requires hospitalization. Then the patient had left-sided pneumonia.
 
Manufacturer Narrative
Investigation summary: customer return samples are intact and did not show any evidence of abnormality in package or product which can lead to sterility compromise and cause reaction / phlebitis. The team inspected the return sample for lot# 17d2841k & 17c1041g. The team inspected the return samples, in which no manufacturing defect observed in terms of package integrity and sterility compromise. The team also checked the burst strength of the unit pack and found within the specification limit. Our quality engineer was unable to verify the reported complaint of inflammatory reactions. The team inspected the retain sample from the same lot, in which no manufacturing defect observed in terms of package integrity and sterility compromise a complaint history check was performed and this is the 2nd related complaint reported with the defect/condition of irritation/ inflammation with lot #17d2841k regarding item #391451. The team investigated the test records of customer reported lot number, the product confirm to sterility specification. The team will monitor the defect and if confirmed will take actions appropriately. Investigation conclusion: as root cause is not determined and defect is not confirmed, no corrective and preventive action is required. There are also other factors involved during practices such as insertion technique, condition of skin, health of patient, the drug used, storage condition of product etc. Causing redness, swelling on the area of application.
 
Event Description
It was reported that after use of a bd venflon¿ 2 pro safety shielded iv catheter the patient experienced a strong inflammatory reaction (a fever has occurred, symptoms of a local inflammation of the forearm of the right hand with extensive infiltration above the elbow area). The removal of the puncture and local treatment of the compresses were ordered and antibiotics were included. Currently perceptible organized abscesses. Surgically consulted, the abscess was notched without obtaining pus. The parameters of inflammation and fever tend to increase. Currently, the patient's condition requires hospitalization. Then the patient had left-sided pneumonia.
 
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Brand NameBD VENFLON¿ 2 PRO SAFETY SHIELDED IV CATHETER
Type of DeviceINTERVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key7627422
MDR Text Key111980115
Report Number2243072-2018-00374
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,health professional,o
Type of Report Initial,Followup,Followup
Report Date 09/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number391451
Device Lot NumberSEE H.10.
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/21/2018 Patient Sequence Number: 1
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