VENFLON PRO 0.9MM X 25MM

Report

Report Number: 2243072-2020-01615
Event Type: Injury
Date Received: October 9, 2020
Date of Event: September 14, 2020
Report Date: October 21, 2020
Manufacturer: BECTON DICKINSON
Product Code: FOZ
PMA / PMN Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BE
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 10/16/2020 H.6. INVESTIGATION: THE SAMPLE WAS RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE RETURNED (1) VENFLON PRO 0.9MM X 25MM FROM LOT # 0032456/006395/0032455 PRODUCT # 393202 WITH THE REPORTED ISSUE OF ¿WHEN THE NURSE WAS WITHDRAWING THE CATHETER VENFLON PRO 22G, THE POLYURETHANE PART STAYED IN PLACE IN THE HAND VEIN OF THE PATIENT. IT WAS NECESSARY TO REALIZE A SMALL SURGERY TO WITHDRAW THIS PLASTIC PART OUT OF THE HAND. THAT'S THE 1ST CASE IN THIS WARD: PSYCHIATRIC UNIT.¿ DHR REVIEWED FOUND NO NON-CONFORMITIES. ONE SAMPLE HAS BEEN RECEIVED BY BD FOR INVESTIGATION. THE SAMPLE WAS INVESTIGATED FOR THE INDICATED DEFECTS IN THE COMPLAINTS. THE INVESTIGATING TEAM HAS DISINFECTED THE DECONTAMINATED AND BLOOD SOAKED SAMPLE FOR INVESTIGATION. UPON INVESTIGATING THE SAME UNDER THE SMART SCOPE WE FOUND THE CATHETER HAD A NEAT AND SHARP CUT AS IF IT HAS BEEN CUT BY A SHARP BLADE OR SCISSOR/ KNIFE. THE PICTURE CLEARLY INDICATES THAT THE BROKEN PIECE LEFT INSIDE THE PATIENT HAS OCCURRED AFTER THE CATHETER WAS CUT. BASED ON THE INVESTIGATION DONE ON THE RECEIVED SAMPLES BY THE INVESTIGATION TEAM, THE DEFECTS IS NOT CONFIRMED. H3 OTHER TEXT : SEE H.10

Description of Event or Problem · 0

IT WAS REPORTED THAT VENFLON PRO 0.9MM X 25MM HAD THE CATHETER BREAK. THIS RESULTED IN A NEED FOR MEDICAL INTERVENTION TO HAVE PART OF THE CATHETER SURGICALLY REMOVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THE NURSE WAS WITHDRAWING THE CATHETER VENFLON PRO 22G, THE POLYURETHANE PART STAYED IN PLACE IN THE HAND VEIN OF THE PATIENT. IT WAS NECESSARY TO REALIZE A SMALL SURGERY TO WITHDRAW THIS PLASTIC PART OUT OF THE HAND. THAT'S THE 1ST CASE IN THIS WARD: PSYCHIATRIC UNIT."

Additional Manufacturer Narrative · 1

MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0032456. MEDICAL DEVICE EXPIRATION DATE: 2023-01-31. DEVICE MANUFACTURE DATE: 2020-02-11. MEDICAL DEVICE LOT #: 0063895. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. DEVICE MANUFACTURE DATE: 2020-03-03. MEDICAL DEVICE LOT #: 0032455. MEDICAL DEVICE EXPIRATION DATE: 2023-01-31. DEVICE MANUFACTURE DATE: 2020-02-29. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4). THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

Description of Event or Problem · 1

IT WAS REPORTED THAT VENFLON PRO 0.9MM X 25MM HAD THE CATHETER BREAK. THIS RESULTED IN A NEED FOR MEDICAL INTERVENTION TO HAVE PART OF THE CATHETER SURGICALLY REMOVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THE NURSE WAS WITHDRAWING THE CATHETER VENFLON PRO 22G, THE POLYURETHANE PART STAYED IN PLACE IN THE HAND VEIN OF THE PATIENT. IT WAS NECESSARY TO REALIZE A SMALL SURGERY TO WITHDRAW THIS PLASTIC PART OUT OF THE HAND. THAT'S THE 1ST CASE IN THIS WARD: PSYCHIATRIC UNIT."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1124302	VENFLON PRO 0.9MM X 25MM	INTRAVASCULAR CATHETER	FOZ	BECTON DICKINSON		SEE H.10.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention