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

Catalog Number 393226

Device Problems Unsealed Device Packaging (1444); Device Packaging Compromised (2916)

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

Event Date 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: no sample and no photo was returned for the investigation of this complaint.Investigation conclusion: no sample and no photo was returned for investigation.Root cause description: the root cause cannot be determined as there is no sample and no photo returned.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.) dhr- reviewed lot master for batch #7207496.No related qn issued for this batch.

Event Description

It was reported that before use, a bd venflon¿ pro safety peripheral safety iv catheter package was found open.¿it looks like the plastic is exposed to high heat.¿ there was no report of injury or medical intervention needed.

• 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: 7113213
• MDR Text Key: 95079465
• Report Number: 8041187-2017-00245
• 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: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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