MAUDE Adverse Event Report: TEVA MEDICAL LTD., MIGADA SITE TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number MG412112

Device Problem Use of Device Problem (1670)

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

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

[(b)(4)].

Event Description

Upon completion of the investigation, no link was observed to any particulate matter, as described in the verbal complaint, in the drip chamber at the completion of the drug infusion while using tevadaptor with an infusion of interleukin by prometheus.As part of the investigation, the leaflet of interleukin ii ("proleukin" of "prometheus") was examined and the following warning was found: "in-line filters should not be used when administering proleukin".The tevadaptor does have an in-line filter.Therefore, the conclusion is that the incident occurred due to improper use.For complete details refer to the (b)(4) complaint report.

• Brand Name: TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Type of Device: TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): TEVA MEDICAL LTD., MIGADA SITE; eli horvitz 1 (p.o. box 888); north industrial zone; kiryat shmona, 11018 01; IS 1101801
• Manufacturer (Section G): TEVA MEDICAL LTD., MIGADA SITE; 1 eli horvitz 1 (p.o. box 888); north industrial zone; kiryat shmona, 11018 01; IS 1101801
• Manufacturer Contact: david bonilla ; 1070 horsham road; north wales, PA 19454 ; 2155913000
• MDR Report Key: 7669633
• MDR Text Key: 113416437
• Report Number: 3002807615-2018-00001
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141448
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: MG412112
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 78 YR