MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD VENFLON PRO SAFETY 22GA 0.9MM OD 25MM L; INTRAVASCULAR CATHETER

Catalog Number 393222

Device Problem Packaging Problem (3007)

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

Event Date 10/24/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd venflon pro safety 22ga 0.9mm od 25mm l packaging seal integrity poor/ questionable the following information was provided by the initial reporter: packaging not sealed correctly k2 is a distributor for bd.Their customer informed them that 11 vps product peelpak were not sealed correctly, they were open.The clear plastic part of the peelpak seems to have warped and pulled away from the paper part of the peelpak.The items were not used on any patients.They found 11 defective sku in the box.The rest of the products in the box were sealed correctly.They also checked other boxes of product in their warehouse and no other defects were seen.

Event Description

Packaging not sealed correctly.K2 is a distributor for bd.Their customer informed them that 11 vps product peelpak were not sealed correctly, they were open.The clear plastic part of the peelpak seems to have warped and pulled away from the paper part of the peelpak.The items were not used on any patients.They found 11 defective sku in the box.The rest of the products in the box were sealed correctly.They also checked other boxes of product in their warehouse and no other defects were seen.

Manufacturer Narrative

Our quality engineer inspected the 11 samples and photos submitted for evaluation.The reported issue of packaging seal integrity poor/ questionable was confirmed upon inspection of the samples.In the photos, droplets of a transparent substance were observed.Analysis of the sample showed that the bottom web of the unit packaging had shrunk and become deformed near the end cap area of the vps causing it to be forced opened at the opening tab.Grid marks were also seen on the bottom web, meaning the sealing process had been completed and the seal width passed inspection.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.Based on a defect simulation performed on similar packaging material, the product could have been subjected to temperature up to 80 degrees celsius.There is no process in the manufacturing that could cause the product to be exposed to such temperatures.The probable root cause for the deformed packages could be due to product being exposed to heat during handling (cargo transportation, storage, loading and unloading, etc.).However, there is no changes to supplier for the transportation.Therefore, the root cause cannot be confirmed.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.

• Brand Name: BD VENFLON PRO SAFETY 22GA 0.9MM OD 25MM L
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18381563
• MDR Text Key: 331490458
• Report Number: 9610847-2023-00355
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903932221
• UDI-Public: (01)00382903932221
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

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: Other
• Device Catalogue Number: 393222
• Device Lot Number: 3136937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2023
• 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