MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 18 G X .32 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 393226

Device Problems Melted (1385); Delivered as Unsterile Product (1421); Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2017

Event Type  malfunction  

Manufacturer Narrative

6v.Investigation: 12 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.1 photo was returned for the investigation of this complaint.From the photo, it appeared that the packaged had been subjected to 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.There is no process in the manufacturing facility that could cause this nonconformance.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 packaging on an 18 g x.32 mm bd venflon¿ pro safety peripheral safety iv catheter appears to be melted causing a sterility issue.This was observed before use and there was no report of injury or medical interventions.

• Brand Name: 18 G X .32 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7022500
• MDR Text Key: 92862184
• Report Number: 8041187-2017-00170
• 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: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• 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: 7207496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2017
• 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