MAUDE Adverse Event Report: BECTON DICKINSON VENFLON I 18GA 1.2 MM X 45MM; INTERVASCULAR CATHETER

Catalog Number 391593

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Hypersensitivity/Allergic reaction (1907); Phlebitis (2004)

Event Date 10/03/2019

Event Type  Injury  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is not registered with the fda.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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 an allergic reaction occurred after use with a venflon i 18ga 1.2 mm x 45mm.The following information was provided by the initial reporter ((b)(6) translation), "om multispeciality hospital was using venflon i (cannula) all the areas but since last two days they are facing issue as the the patient is getting fever and riger when the have inserted the venflon i also it is geting dislodge and showing complications like phlebitis within a day and due to which dr.Has to postponed the surgery in their two to three patient as it had showing similar issue in all, the doctor had stop using our brand and started using other brand of iv cannula and he is not facing any issue.

Event Description

It was reported that an allergic reaction occurred after use with a venflon i 18ga 1.2 mm x 45mm.The following information was provided by the initial reporter (india translation), "om multispeciality hospital was using venflon i (canula) all the areas but since last two days they are facing issue as the the patient is getting fever and riger when the have insreted the venflon i also it is geting dislodge and showing complications like phlebitis within a day and due to which dr.Has to postponed the surgery in their two to three patient as it had showing similar issue in all, the doctor had stop using our brand and started using other brand of iv canula and he is not facing any issue.

Manufacturer Narrative

Investigation summary: no samples (including photos) were returned for the reported issue of ¿patient is getting fever and rigor when the have inserted the venflon i also it is getting dislodge and showing complications like phlebitis within a day¿ with lot number 9031707 regarding item # 391593 so the complaint could not be confirmed, and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.The team investigated retention samples of material number 391593 for batch number 9031707.The team reviewed the sterility check report and the bi study on the lot number 9031707 and did not find any defect.After a thorough investigation and review of received complaint on retention samples and reviewing the sterility test reports and the bi report of the lot number 9031707, the team found that the product was sterile and safe for use before dispatching it to the market.Dhr reviewed found no non-conformities.As no samples and/or photo(s) were received the investigation concluded that bd was not able to duplicate or confirm the indicated failure.The exact root cause cannot be confirmed.Based on the above, no additional investigation and no capa is required at this time.

• Brand Name: VENFLON I 18GA 1.2 MM X 45MM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9247813
• MDR Text Key: 171980954
• Report Number: 2243072-2019-02406
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

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 Expiration Date: 01/31/2024
• Device Catalogue Number: 391593
• Device Lot Number: 9031717
• Initial Date Manufacturer Received: 10/05/2019
• Initial Date FDA Received: 10/28/2019
• Supplement Dates Manufacturer Received: 10/05/2019
• Supplement Dates FDA Received: 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention