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

Catalog Number 393222

Device Problems Leak/Splash (1354); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2023

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 shielded iv catheter needle was difficult to remove and blood leaked out as a result.The following information was provided by the initial reporter: "the cannulas cannot be withdrawn, patients always bleed when the cannula is being removed.".

Event Description

It was reported that the bd venflon¿ pro safety shielded iv catheter needle was difficult to remove and blood leaked out as a result.The following information was provided by the initial reporter: "the cannulas cannot be withdrawn, patients always bleed when the cannula is being removed.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 27-mar-2023 h6: investigation summary our quality engineer inspected the 3 photos, 1 used sample and 119 representative samples submitted for evaluation.The used sample was returned with two empty packages with batches 2173218 and 2201201 of catalog 393222.The reported issue of leakage was not confirmed upon inspection and testing of the samples.The one used sample returned was damaged during the decontamination process and was unable to be properly examined for the investigation.A random selection of the representative samples underwent our internal leakage testing.50 pieces from batch 2173218 were selected and subjected to visual inspection and catheter adapter leak testing.All samples passed with no damages or defects observed and no leakage present.We are unable to determine a root cause of the failure since the failure mode could not be replicated in our sample evaluations.Production records were reviewed, and this batch meets our manufacturing specification requirements.

Event Description

It was reported that the bd venflon¿ pro safety shielded iv catheter experienced blood leaked from injection port.The following information was provided by the initial reporter: "(b)(6) 2023 - "the sales rep confirmed the following on the phone: the cannulas cannot be withdrawn, patients always bleed when the cannula is being removed.The sales rep will visit the customer during the week and inform us about samples." (b)(6) 2023: "the reporting senior physician was quite clear when reporting the incident.It is only about blood leakage from the injection port during therapy.Therefore, the product was removed.The application process of the vps took place without complications.There was no needlestick injury (which is also difficult with a vps).The senior physician emphasized that she has 40 years of experience.Obviously, people don't prick each other there anymore."".

Manufacturer Narrative

The following fields were corrected: b5.Describe event or problem - customer corrected their complaint.It was reported that the bd venflon¿ pro safety shielded iv catheter experienced blood leaked from injection port.The following information was provided by the initial reporter: "(b)(6) 2023 - "the sales rep confirmed the following on the phone: the cannulas cannot be withdrawn, patients always bleed when the cannula is being removed.The sales rep will visit the customer during the week and inform us about samples." (b)(6) 2023: "the reporting senior physician was quite clear when reporting the incident.It is only about blood leakage from the injection port during therapy.Therefore, the product was removed.The application process of the vps took place without complications.There was no needlestick injury (which is also difficult with a vps).The senior physician emphasized that she has 40 years of experience.Obviously, people don't prick each other there anymore."" h.6.Imdrf annex a grid - medical device problem code.A0504 - leak/splash.The customer modified/clarified their complaint with additional information.(b)(4) is incorrect and should be considered removed from the initial mdr.

• Brand Name: BD VENFLON¿ PRO SAFETY SHIELDED 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 ; 8448235433
• MDR Report Key: 16440780
• MDR Text Key: 310350025
• Report Number: 8041187-2023-00062
• 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,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 393222
• Device Lot Number: 2173218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2022
• 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