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

Catalog Number 391454

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 11/14/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.The manufacturing location for this product is (b)(4).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.The customer returned samples are intact and did not show any evidence of abnormality in package or product.Bd visually inspected 100 retain samples for any damage on the primary packaging, catheter & cannula tip for lot# 13l0141h.All samples found in ok condition.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.The complaint history for the lot# 13l0141h was reviewed and till 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 # 13l0141h.Log sheet ¿ printing shifting problem is recorded in packaging process during manufacturing of lot 13l0141h.Stoppages ¿ station 21 proximity sensor problem & cannula orientation problem stoppages occurred in va assembly process during manufacturing of lot # 13l0141h.Others ¿ lot 13l0141h was sterilized in sterilization cycle# 13111121 (sterilization process parameter, product sterility test report & biological indicator sterility test report attached), no discrepancy observed during the sterilization process.Conclusion: 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: 7097394
• MDR Text Key: 94194566
• Report Number: 2243072-2017-00380
• 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 Expiration Date: 10/31/2018
• Device Catalogue Number: 391454
• Device Lot Number: 13L0141H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2013
• 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