MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON IV CANNULA 22G; INTRAVASCULAR CATHETER

Catalog Number 391451

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 03/02/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.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.Date of event is unknown; awareness date has been used for this field.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 while using bd venflon iv cannula 22g the catheter splits.This occurred 3 times.There was no report of patient impact.The following information was provided by the initial reporter: the plastic part ruptures in blood vessels.

Manufacturer Narrative

H6: investigation summary, the photo was received by bd for evaluation.A quality engineer was able to review the photo of a venflon eu from lot # 1086742 regarding item # 391451 with the reported issue of ¿difficulty insertion(interlink)¿.The investigating team has used the retention samples from lot # 1086742 regarding item # 391451 for investigating the reported defect.The investigation and simulation were carried out on ten retention samples where the investigating team has visually tested the samples and no difficulty insertion(interlink) was found.Since there is no sample and the photograph shared by the customer did not help us to confirm the reported defect of difficulty insertion(interlink), this defect is unconfirmed.The root cause cannot be determined as the retention samples did not show any sample simulating difficulty insertion(interlink) in them.There is no sample or photograph shared by the customer to understand and confirm the defect or to analyze the root cause.H3 other text : see h10.

Event Description

It was reported while using bd venflon iv cannula 22g the catheter splits.This occurred 3 times.There was no report of patient impact.The following information was provided by the initial reporter: the plastic part ruptures in blood vessels.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval? yes.D9: returned to manufacturer on: 8-jun-2022.H6: investigation summary: there are 125 sample and 01 photograph received along with the reported complaint of difficulty insertion (interlink).The investigating team has used the retention samples of material number 391451 and lot number 1086742 for investigating the reported defect.The investigation and simulation were carried out on ten retention samples where the investigating team has visually tested the samples for difficulty insertion (interlink) and no difficulty insertion (interlink) was found in the ten retention samples.From the 125 received samples there were 42, 42, and 41 in three boxes.The investigation team has taken five samples from each box to check for needle penetration test and needle pull force test.None of the returned samples showed any out of specification for both the test.The test results are attached along with the report of investigation for cross verification.The root cause cannot be determined as the return samples did not show any sample with any defect on needle penetration or needle pull force test variation from standard.The defect could not be confirmed on the reported defect.

Event Description

It was reported while using bd venflon iv cannula 22g the catheter splits.This occurred 3 times.There was no report of patient impact.The following information was provided by the initial reporter: the plastic part ruptures in blood vessels.

• Brand Name: BD VENFLON IV CANNULA 22G
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13792493
• MDR Text Key: 287835836
• Report Number: 2243072-2022-00364
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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,Followup
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 391451
• Device Lot Number: 1086742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2022
• Initial Date FDA Received: 03/17/2022
• Supplement Dates Manufacturer Received: 04/06/2022; 06/20/2022
• Supplement Dates FDA Received: 04/22/2022; 07/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2021
• 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