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

Catalog Number 393222

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 04/25/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 venilon¿ pro safety shielded iv catheter packaging unit was damaged, exposing the product and compromising its sterility.The following information was provided by the initial reporter: "customer reported that some venilon pro safety g22 products were supplied to them with distorted packaging (the inner package immediate to the product is exposed); the package is rugged as compared to the normal smooth curvature of the same product".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 05-may-2022.H.6.Investigation: one actual sample of batch 1203323 were received by our quality team for evaluation.The returned sample was subjected to visual inspection and penetration testing.From the sample, the team observed that the bottom web of the unit package had shrunk and become deformed near the end cap area of the venflon pro safety part causing it to be forced open at the opening tab.The returned sample passed the penetration testing, and no blunt needle was observed.Further visual inspection of the sealing features was performed, and a grid mark was observed on the bottom web.This shows that the sealing process was completed, and the seal width passed the inspection criteria.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.The manufacturing process was reviewed.There is no part of the manufacturing process that would cause the reported defect.Based on the defect simulation performed on similar packaging materials, the product could have been subjected to a temperature up to 80 degrees celsius.There is no process during manufacturing that could cause the product to be exposed to such temperatures.The probable root cause for the deformed package could be due to the product being exposed to heat during handling (cargo transportation, storage, loading and unloading, etc).

Event Description

It was reported that the bd venflon¿ pro safety shielded iv catheter packaging unit was damaged, exposing the product and compromising its sterility.The following information was provided by the initial reporter: "customer reported that some venflon pro safety g22 products were supplied to them with distorted packaging (the inner package immediate to the product is exposed); the package is rugged as compared to the normal smooth curvature of the same product.".

• 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 ; 8015296192
• MDR Report Key: 14428048
• MDR Text Key: 291936255
• Report Number: 8041187-2022-00253
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: KE
• 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
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 393222
• Device Lot Number: 1203323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2021
• 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