MAUDE Adverse Event Report: CAREFUSION LL VLV ADPT(STAND ALONE); INTRAVASCULAR ADMINISTRATION SET

Model Number 2000E CHINA

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that ll vlv adpt (stand alone) was blocked during use.The following information was provided by the initial reporter: on (b)(6), when the picc outpatient department normally gave the patient the picc maintenance, the infusion connector did not flow the drug fluid, which affected the use of picc.The infusion connector was replaced and could be used normally afterwards.

Event Description

It was reported that ll vlv adpt(stand alone) was blocked during use.The following information was provided by the initial reporter: on (b)(6), when the picc outpatient department normally gave the patient the picc maintenance, the infusion connector did not flow the drug fluid, which affected the use of picc.The infusion connector was replaced and could be used normally afterwards.

Manufacturer Narrative

A 2000e china product was not available for investigation; however the customer confirmed that the complaint sample was from lot 17077698.Further information wan not available to assist the investigation.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 17077698 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.The connecting product in use at the time of the customer's experience was not available for investigation and therefore it has not been possible to confirm if this may have contributed to the customer's experience.A review of the customer feedback database indicates that there are a small number of similar reports; however, these complaints have not been attributable to a smartsite product defect.H3 other text: see section h.10.

• Brand Name: LL VLV ADPT(STAND ALONE)
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10216165
• MDR Text Key: 202583804
• Report Number: 9616066-2020-01938
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Model Number: 2000E CHINA
• Device Catalogue Number: 2000E CHINA
• Device Lot Number: 17077698
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (B)(6) 2020.; (B)(6) 2020.
• Patient Outcome(s): Other