MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON¿ IV CANNULA WITH FEP POLYMER; INTRAVASCULAR CATHETER

Catalog Number 391453

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Hematoma (1884)

Event Date 09/15/2021

Event Type  malfunction  

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 the bd venflon¿ iv cannula with fep polymer split once the cannula was removed.This occurred 5 separate times during use.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter, translated from polish to english: "during cannulation of the peripheral vein a bulge was formed just behind the puncture site which resulted in the discontinuity of the vessel.Then a subcutaneous hematoma developed.After immediate removal of the cannula, delamination of the plastic part was observed.This situation happened many times.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 10/22/2021.H.6.Investigation: the samples were received by bd for evaluation.A quality engineer was able to review the returned sample of (2) venflon 18ga from lot # 0304783 product # 391453 with the reported issue that ¿during cannulation of the peripheral vein a bulge was formed just behind the puncture site which resulted in the discontinuity of the vessel.Then a subcutaneous hematoma developed.After immediate removal of the cannula, delamination of the plastic part was observed.This situation happened many times¿.The dhr of material number 391453 and lot number 0304783 was checked and no quality notifications was recorded on this lot.Two samples and no photographs were received from the customer and were used for investigation of the reported defects.The two samples received from the customer were investigated visually for the reported defect of needle passing through the catheter and the team confirmed the defect reported by the customer.The investigation team also used retention samples of material code 391453 and lot number 0304783 for investigating the reported defect of the plastic part.The retention samples were visually inspected for the needle passing through the catheter and none of the ten retention samples showed any such defect in them.The next two sets of five samples each of retention samples were used for testing the stretching and strength of the catheter.Photograph of simulation performed in the laboratory.This was checked by test performed in the laboratory on the retention samples to reconfirm the reported defect.Simulation of the ptfe (catheter) stretching the tubing by hand simulation: ptfe tube is pulled by hand.Result: ptfe tube is elongated in length without any breakage of tube.Simulation of the stretching of ptfe (catheter) tube done by equipment (instron): quality test - catheter pull test is performed to check amount of force required to break ptfe tube.Result: ptfe tube broke at approx.19n force conforms the specification of product (min.15n) none of the 10 retention samples showed any defect in plastic part(ptfe) (catheter) observed in them.The defect of the needle passing through the catheter could probably be due to wrong practice issue.H3 other text : see h.10.

Event Description

It was reported that the bd venflon¿ iv cannula with fep polymer split once the cannula was removed.This occurred 5 separate times during use.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter, translated from polish to english: "during cannulation of the peripheral vein a bulge was formed just behind the puncture site which resulted in the discontinuity of the vessel.Then a subcutaneous hematoma developed.After immediate removal of the cannula, delamination of the plastic part was observed.This situation happened many times.".

• Brand Name: BD VENFLON¿ IV CANNULA WITH FEP POLYMER
• Type of Device: INTRAVASCULAR 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12668819
• MDR Text Key: 278183001
• Report Number: 2243072-2021-02560
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 391453
• Device Lot Number: 0304783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1