MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON PRO SAFETY 18GA 1.3MM OD 45MM L; INTRAVASCULAR CATHETER

Catalog Number 393227

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/22/2024

Event Type  Injury  

Event Description

It was reported that the bd venflon pro safety 18ga 1.3mm od 45mm l catheter broke/separated after placement.The following information was provided by the initial reporter translated from german to english: a piece of the venflon 45mm 393227 has broken off at the front.When the venflon, which had been in the crook of the elbow for several days, was removed, it was discovered that a considerable part of the plastic catheter in the vein was missing.The dressing was also examined for plastic particles.The removed venflon was kept for possible further examination.Measures taken: informing the patient and documentation in the medical history.Phlebotomy / x-ray of the arm and thorax / no plastic surgery possible request to contact and meet with bd to discuss the case.

Manufacturer Narrative

B.3.The date received by manufacturer has been used for this field.G.1.Franklin lakes has been listed as the manufacturer.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

A piece of the venflon 45mm 393227 has broken off at the front.When the venflon, which had been in the crook of the elbow for several days, was removed, it was discovered that a considerable part of the plastic catheter in the vein was missing.The dressing was also examined for plastic particles.The removed venflon was kept for possible further examination.Measures taken: informing the patient and documentation in the medical history.Phlebotomy / x-ray of the arm and thorax / no plastic surgery possible request to contact and meet with bd to discuss the case.

Manufacturer Narrative

As no sample and no photo were returned, further investigation cannot be performed.No similar quality notification was raised for the reported defect in the past 12 months.Therefore, the root cause cannot be determined.Complaint trend would be monitored and complaint will be reopened when sample is returned.H3 other text : see h10 manufacture narrative.

Event Description

A piece of the venflon 45mm 393227 has broken off at the front.When the venflon, which had been in the crook of the elbow for several days, was removed, it was discovered that a considerable part of the plastic catheter in the vein was missing.The dressing was also examined for plastic particles.The removed venflon was kept for possible further examination.Measures taken: informing the patient and documentation in the medical history.Phlebotomy / x-ray of the arm and thorax / no plastic surgery possible request to contact and meet with bd to discuss the case.

Manufacturer Narrative

Correction supplemental for a code as no sample and no photo were returned, further investigation cannot be performed.No similar quality notification was raised for the reported defect in the past 12 months.Therefore, the root cause cannot be determined.Complaint trend would be monitored and complaint will be reopened when sample is returned.H3 other text : see h10 manufacture narrative.

• Brand Name: BD VENFLON PRO SAFETY 18GA 1.3MM OD 45MM L
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19093824
• MDR Text Key: 339981231
• Report Number: 2243072-2024-00541
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903932276
• UDI-Public: (01)00382903932276
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2024

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: Health Professional
• Device Catalogue Number: 393227
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 04/26/2024; 04/26/2024
• Supplement Dates FDA Received: 04/29/2024; 05/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other