MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON; PERIPHERAL IV CATHETERS

Catalog Number 391592

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.In this mdr, bd franklin lakes, nj has been listed in sections d.3.And g.1.As the manufacturing site.

Event Description

It was reported that bd venflon internal contents were wet when the package was opened.External packaging appeared to have dried fluid stains.The following information was provided by the initial reporter: when the nurse took out the bd venflon i 20g cannula from the package, she found liquid droplets inside the catheter lumen upon removal of the needle (stylet).This happened while checking the stylet before insertion of the cannula to the patient's arm.The backside of the package, i.E., the paper package seemed as if it had got wet somehow and then it got dried.

Event Description

When the nurse took out the bd venflon i 20g cannula from the package, she found liquid droplets inside the catheter lumen upon removal of the needle (stylet).This happened while checking the stylet before insertion of the cannula to the patient's arm.

Manufacturer Narrative

01 sample was received by bd for evaluation.A quality engineer was able to inspect the returned samples for the reported issue of foreign matter from lot # 3363972 product # (b)(4).The investigating team has also used the retention samples of lot # 3363972 product # (b)(4) for investigating the reported defect.The investigation and simulation were carried out on 01 retention samples where the investigating team has visually tested the samples for foreign matter and no foreign matter was found in the 01 retention sample.The original customer returned sample was used to investigate the complaint of foreign matter and it was found that the sample did not show any defect of foreign matter in it.The exact root cause could not be determined.The complaint cannot be confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.

• Brand Name: BD VENFLON
• Type of Device: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18977489
• MDR Text Key: 338571586
• Report Number: 2243072-2024-00445
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903915927
• UDI-Public: (01)00382903915927
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 391592
• Device Lot Number: 3363972
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1