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

Catalog Number 393224

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/24/2022

Event Type  Injury  

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 peripheral safety iv catheter broke from the hub and remained in the patient, requiring surgical intervention to remove it.The following information was provided by the initial reporter: "venflon broken in the patient.He has the external part of the venflon and the operation to remove the broken part in the patient is still ongoing.".

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 05-may-2022.H6: investigation summary: one used sample was received by our quality team for evaluation.The extension set is not a bd product; therefore, no further investigation was performed on it.The used sample was subjected to visual inspection.A clean cut on the broken end of the catheter was observed on the used sample.From the broken edge, no stretched phenomenon or elongation of the catheter tubing can be observed to indicate any issue with the tubing material which could have caused the breakage.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.The manufacturing process was reviewed and there are no sharp edges that could possibly come into contact with the catheter to cause the cut.There is an automated vision inspection system that can detect and reject product not meeting the lie distance requirement.If the catheter is broken in the manufacturing process, the defective part would be rejected by the automated vision inspection system as the product will not have any lie distance.It would also not be possible to use the product if the catheter is broken before use.The probable root cause for the broken catheter could be due to the catheter being cut by a sharp object such as scissors during product removal from the vein.It is stated in the instructions for use ¿do not use scissors at or close to the insertion site.¿ however, as it is not possible to confirm how the product was used and no similar quality notifications have been raised for the reported defect for the past 12 months, the root cause cannot be determined.

Event Description

It was reported that the bd venflon¿ pro safety peripheral safety iv catheter broke from the hub and remained in the patient, requiring surgical intervention to remove it.The following information was provided by the initial reporter: "venflon broken in the patient he has the external part of the venflon and the operation to remove the broken part in the patient is still ongoing.".

• Brand Name: BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
• 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: 14134946
• MDR Text Key: 289430919
• Report Number: 8041187-2022-00194
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 05/12/2022

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 Expiration Date: 02/29/2024
• Device Catalogue Number: 393224
• Device Lot Number: 1078947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 04/18/2022
• Supplement Dates Manufacturer Received: 05/12/2022
• Supplement Dates FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2021
• 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
• Patient Outcome(s): Required Intervention