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

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.

• Brand Name: BD VENFLON¿ 2 PRO SAFETY SHIELDED IV CATHETER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7627422
• MDR Text Key: 111980115
• Report Number: 2243072-2018-00374
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 391451
• Device Lot Number: SEE H.10.
• Initial Date Manufacturer Received: 05/28/2018
• Initial Date FDA Received: 06/21/2018
• Supplement Dates Manufacturer Received: 05/28/2018; 05/28/2018
• Supplement Dates FDA Received: 08/10/2018; 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention