MAUDE Adverse Event Report: BECTON DICKINSON VENFLON 2 PNK 20GA IV CANNULA; CATHETER

Catalog Number 391452

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/11/2021

Event Type  Injury  

Manufacturer Narrative

Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that venflon 2 pnk 20ga iv cannula catheter broke.The following information was provided by the initial reporter: during the removal of the catheter from the patient's left arm and during the examination of the item after removal, it appears that a distal part of the catheter is missing and the remaining part appears to be cut diagonally.The patient is about (b)(6) years old who came for surgery to remove the appendicitis and was hospitalized on the 10/4.On 11/4 the catheter was removed and then they noticed that a piece of the catheter was missing(as describe on the complaint).Soft tissue and skeletal ultrasound, chest x-ray and heart echo were performed but they didn¿t found the missing part.A thrombus was found that was probably related to a venous thrombosis and it could not be confirmed or ruled out whether the foreign body was inside the blood clot.The patient is also examined by a vascular surgeon.There were no complaints of swelling, redness or pain on the insertion site or arm.On 14/4 the patient was released from the hospital.

Event Description

It was reported that venflon 2 pnk 20ga iv cannula catheter broke.The following information was provided by the initial reporter: during the removal of the catheter from the patient's left arm and during the examination of the item after removal, it appears that a distal part of the catheter is missing and the remaining part appears to be cut diagonally.The patient is about 40 years old who came for surgery to remove the appendicitis and was hospitalized on the 10/4.On 11/4 the catheter was removed and then they noticed that a piece of the catheter was missing(as describe on the complaint).Soft tissue and skeletal ultrasound, chest x-ray and heart echo were performed but they didn¿t found the missing part.A thrombus was found that was probably related to a venous thrombosis and it could not be confirmed or ruled out whether the foreign body was inside the blood clot.The patient is also examined by a vascular surgeon.There were no complaints of swelling, redness or pain on the insertion site or arm.On 14/4 the patient was released from the hospital.

Manufacturer Narrative

H.6.Investigation: since no samples (including photos) were returned for the reported issue of ¿distal part of the catheter is missing and the remaining part appears to be cut diagonally¿ with lot number 9340582 regarding item # 391452 the complaint could not be confirmed, and the root cause is undetermined.Dhr was reviewed for the product test.No discrepancy was reported and recorded in dhr in customer reported lot # 9340582.The investigating team has used the retention samples of 9340582 to check for blockage, blunt and or catheter pull force variations.No defects were found in the retention samples on investigation.Ten retention samples were tested to measure the catheter pull force on instron utm machine to check the strength of catheter tubing.The retention samples were tested for catheter blunt tip verification test on latex sheet drum tests and on instron.All the test results did not show any variation in the speciation from the standards.There is no evidence of cannula tip damage, catheter damage or ppft tube damage in any of the retention samples.Tests performed on ten retentions samples were within conformance to bd specification.The customer complaint could not be confirmed.As no samples and/or photo(s) were received the investigation concluded that bd was not able to duplicate or confirm the indicated failure.

• Brand Name: VENFLON 2 PNK 20GA IV CANNULA
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11823719
• MDR Text Key: 254648680
• Report Number: 2243072-2021-01464
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 05/26/2021

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?: Yes
• Device Operator: Other
• Device Catalogue Number: 391452
• Device Lot Number: 9340582
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 05/13/2021
• Supplement Dates Manufacturer Received: 05/26/2021
• Supplement Dates FDA Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR