MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON¿ 2 PRO SAFETY SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 391457

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 11/14/2017

Event Type  Injury  

Manufacturer Narrative

The date received by manufacturer has been used for this field.The manufacturing location for this product is (b)(6).This site is not registered with the fda.Therefore the manufacturing site (b)(4) was used.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 a patient developed an infection after a bd venflon¿ 2 pro safety shielded iv catheter was inserted.Serious injury and medical intervention required.

Manufacturer Narrative

Investigation results: bd (b)(4) received 5 representative samples from the customer facility for investigation.Customer return samples are intact and did not show any evidence of abnormality in package or product which can lead to sterility compromise and cause reaction / phlebitis.Bd visually inspected 100 retain samples for any damage on the primary packaging, catheter & cannula tip for lot# 17a0341h.All samples found in ok condition.The complaint history for the lot# 17a0341h was reviewed and up to the reported incident date no complaint had been registered against the above lot in terms of package integrity and sterility compromise which may cause reaction / phlebitis.Dhr was reviewed for the product test.The entire routing test for reported lot found within the specification limit.No discrepancy was reported and recorded in dhr in customer reported lot # 17a0341h.The team inspected the customer return samples, in which no any manufacturing defect observed in terms of package integrity, seal strength and sterility compromise.The team investigated the test records of customer reported lot number, the product conform to sterility specification.The team also checked the seal strength of the unit pack performed in routine testing, the results were acceptable and conforms to specification limit of the product.The defect is not confirmed.Conclusions: the exact root cause is not identified.Based on an evaluation of severity and occurrence, it was determined that no corrective action is required.

• Brand Name: BD VENFLON¿ 2 PRO SAFETY SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7097269
• MDR Text Key: 94193406
• Report Number: 2243072-2017-00379
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: RO
• 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,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 391457
• Device Lot Number: 17A0341H
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Required Intervention