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

Catalog Number 393224

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 11/07/2021

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 shielded iv catheter experienced the catheter adapter being unable to connect with the mating component, and blood exposure.The following information was provided by the initial reporter: after placing the bd vps device and taking a blood sample, the adapter slips off and the user has contact with blood.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for evaluation: yes.D10: returned to manufacturer on: 2021-11-22.H6: investigation summary: one used sample and one blood collection adapter from sarstedt were received by our quality team for evaluation.As the blood collection adapter are not a bd product, no further investigation was performed on them.The sample was subjected to visual inspection and luer cone measurement.All inspection results passed, and no abnormalities were observed.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 returned sample passed the visual inspection and luer cone inspection.No abnormality was observed.The returned sample was also able to connect with the sarstedt adapter properly.As the disconnection was not observed from the returned sample, the customer experience cannot be determined.The probable root cause for the adapter to slip out could be due to the user not fitting the adapter with the hub tight enough or lubrication migration to the cannula hub, which can occur with age.The lubrication could have reduced the friction of the interference fit between the cannula hub luer and the sarstedt adapter and could have resulted in the disconnection.A project was previously initiated for the luer disconnection, and this batch was produced after the actions were implemented.The machine history was reviewed, and no abnormalities were observed.Based on the product design, lubricant is applied to ease needle separation, and the migration of lubricant from the needle cap to the cannula cannot be eliminated completely.Based on the quality team¿s investigation, the root cause of this incident cannot be determined.

Event Description

It was reported that the bd venflon¿ pro safety shielded iv catheter experienced the catheter adapter being unable to connect with the mating component, and blood exposure.The following information was provided by the initial reporter: after placing the bd vps device and taking a blood sample, the adapter slips off and the user has contact with blood.

• Brand Name: BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER
• Type of Device: INTERVASCULAR 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12956922
• MDR Text Key: 286445807
• Report Number: 8041187-2021-01025
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 393224
• Device Lot Number: 1049821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• 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