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

Catalog Number 393226

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation: two (2) photos were returned for the investigation of this complaint.From the photo, it appeared that the packages had been subjected to a high temperature which causes the bottom web to shrink and become deformed near the end cap area of the vps part causing it to be force opened at the opening tab.5 actual samples were returned for the investigation of this complaint.The bottom web of the unit package had shrunk and become deformed near the end cap area of the vps part causing it to be force opened at the opening tab.Visual inspection was performed on the sealing features of the returned samples.Grid mark was observed on the bottom web.This shows that sealing process has been completed and the seal width is within specification.A review of the device history record revealed no irregularities during the manufacture of the reported lot numbers.A manufacturing review revealed no abnormalities with preventative maintenance, calibration, or equipment.There is no process in the manufacturing facility that could cause this nonconformance.Visual inspection was performed on the returned unit package.Grid mark was observed on the bottom web.This shows that sealing process has been completed and the seal width is within specification.There was 100% sorting done on sterile parts for this affected batch prior to shipment.Based on the above investigation result, the reported nonconformance occurred after the product was packed in our manufacturing and sterilization process.Therefore, the probable root cause could be due to temperature gradient experience by the product during handling (transportation, storage, loading and unloading, etc.).

Event Description

It was reported that the customer received a shipment of bd venflon¿ pro safety peripheral safety iv catheter(s) that were not sealed and sterile.There was no report of injury or medical interventions.

• Brand Name: BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
• Type of Device: SAFETY PORTED 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7060365
• MDR Text Key: 93620874
• Report Number: 8041187-2017-00181
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2017

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: Other
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 393226
• Device Lot Number: 7207498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2017
• 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
• Patient Outcome(s): Other