MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON¿ (IV CANNULA FOR CONTINUOUS AND INTERMITTENT THERAPY); INTRAVASCULAR CATHETER

Catalog Number 391493

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: n/a.Initial reporter phone #: (b)(4).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 stylet hub broke and stuck in the cannula when removing a bd venflon¿ pro safety peripheral safety iv catheter.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation results: our quality engineer was able to verify the reported complaint.The photo received shows an incorrectly assembled component.A stock check was performed and all checked from the lot were found in good condition.Due to unavailability of actual defective sample, simulation and further investigation could not be performed.The complaint history for the lot was reviewed and no complaint was recorded for the reported defects ¿ damage and incorrectly assembled component.A device history record was reviewed for the product test.The entire routing test for reported lot found within the specification limit.No discrepancy was reported and recorded in dhr in customer reported lot.The team reviewed the process controls of cannula hub molding process, assembly process and packaging process.During the manufacturing of the reported lot, the cannula detachable force and penetration force is checked, for the issues - difficulty in pricking and stylet stuck in cannula while removing as reported, both the forces are found within the specification limit.The team also reviewed the molding process of cannula hub, all process controls were in place and in working condition.100 retention samples of lot# 17e1241l had been visually inspected for any damage and incorrectly assembled component, all samples found in good condition.Log sheet ¿ apet (bottom web) jamming problem, conveyor shifting problem is recorded in fa machine primary packaging process during manufacturing of lot # 17e1241l.Stoppages ¿ ipa dropping problem and station# 21 magazine jamming stoppages occurred in venflon assembly process during manufacturing of lot # 17e1241l.Mold cleaning stoppage occurred in venflon molding process during manufacturing of lot # 17e1241l.Conclusion: there is a chance that during storage and handling, the unit package of product got collapsed and pressed due to stress / pressure of some other material stored above resulting in the bending of cannula and breaking / removal of cannula hub.The exact root cause is not identified.Based on severity and occurrence, it was determined that no corrective action is required.However there is a preventive action proposed.A training is to be provided to concerned line associates to perform in process quality checks more effectively.Target completion date: 15th mar 2018.

Manufacturer Narrative

Medical device brand name correction.The event or problem and medical device brand name fields have been updated to reflect the correct brand name bd venflon¿ (iv cannula for continuous and intermittent therapy).

Event Description

It was reported that the stylet hub was breaking and sticking in the cannula while removing an 18g bd venflon¿ (iv cannula for continuous and intermittent therapy).There was no report of injury or medical intervention.

• Brand Name: BD VENFLON¿ (IV CANNULA FOR CONTINUOUS AND INTERMITTENT THERAPY)
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7184294
• MDR Text Key: 97082552
• Report Number: 2243072-2018-00004
• 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: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 391493
• Device Lot Number: 17E1241L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other