MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY IV CANNULA WITH INSTAFLASH¿; INTRAVASCULAR CATHETER

Catalog Number 393280

Device Problem Break (1069)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 01/12/2023

Event Type  malfunction  

Manufacturer Narrative

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¿ pro safety iv cannula with instaflash¿ broke from the hub and remained in the patient's vein.The patient received an urgent surgical consultation followed by an ultrasound of the affected area.The surgeon was able to locate the foreign body under local anesthesia and remove it.The following information was provided by the initial reporter: "on (b)(6) 2023, in the evening, the patient was inserted a peripheral puncture, and the prescribed medications were administered.The patient reported no abnormalities, and the peripheral puncture was active (left hand wrist).In the morning (b)(6) 2023, during the morning administration of the medication, the patient reported slight pain in the venflon area.The nurse removed the insertion and observed that the plastic part of the venflon stayed in the vein.This fact was immediately reported, and corrective action was taken.No immediate consequences for the patient.The patient was given an urgent surgical consultation.An ultrasound of the vessel was performed.By palpation, the surgeon felt the foreign body and under local anesthesia removed the foreign body from the vein.".

Manufacturer Narrative

H.6.Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd venflon¿ pro safety iv cannula with instaflash¿ broke from the hub and remained in the patient's vein.The patient received an urgent surgical consultation followed by an ultrasound of the affected area.The surgeon was able to locate the foreign body under local anesthesia and remove it.The following information was provided by the initial reporter: "on (b)(6) 2023, in the evening, the patient was inserted a peripheral puncture, and the prescribed medications were administered.The patient reported no abnormalities, and the peripheral puncture was active (left hand wrist).In the morning ((b)(6) 2023), during the morning administration of the medication, the patient reported slight pain in the venflon area.The nurse removed the insertion and observed that the plastic part of the venflon stayed in the vein.This fact was immediately reported, and corrective action was taken.No immediate consequences for the patient.The patient was given an urgent surgical consultation.An ultrasound of the vessel was performed.By palpation, the surgeon felt the foreign body and under local anesthesia removed the foreign body from the vein.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 23-may-2023.Investigation summary: our quality engineer inspected the 1 sample submitted for evaluation.The reported issues of irritation / inflammation, leakage and catheter broke / separated after placement were confirmed upon inspection of the sample.Analysis of the sample showed that multiple cuts and scratches were found at the cannula hub tip near the catheter.A jagged cut was observed on the broken edge of the used sample.A partial cut on the catheter near the cannula hub tip was also observed.We reviewed our manufacturing processes and there were no portions of the manufacturing process that could have resulted in the damages observed.A potential root cause could be related to the application of the device.If the device was used around sharp objects such as using scissor to open the packaging, there is a chance the damages observed could occur.However, we cannot confirm this root cause since we cannot confirm how the product was used.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.

Event Description

It was reported that the bd venflon¿ pro safety iv cannula with instaflash¿ broke from the hub and remained in the patient's vein.The patient received an urgent surgical consultation followed by an ultrasound of the affected area.The surgeon was able to locate the foreign body under local anesthesia and remove it.The following information was provided by the initial reporter: "on (b)(6) 2023, in the evening, the patient was inserted a peripheral puncture, and the prescribed medications were administered.The patient reported no abnormalities, and the peripheral puncture was active (left hand wrist).In the morning (b)(6) 2023), during the morning administration of the medication, the patient reported slight pain in the venflon area.The nurse removed the insertion and observed that the plastic part of the venflon stayed in the vein.This fact was immediately reported, and corrective action was taken.No immediate consequences for the patient.The patient was given an urgent surgical consultation.An ultrasound of the vessel was performed.By palpation, the surgeon felt the foreign body and under local anesthesia removed the foreign body from the vein.".

• Brand Name: BD VENFLON¿ PRO SAFETY IV CANNULA WITH INSTAFLASH¿
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16288086
• MDR Text Key: 308702587
• Report Number: 8041187-2023-00042
• 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,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 393280
• Device Lot Number: 2233029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2022
• 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
• Patient Outcome(s): Required Intervention