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

Catalog Number MG412112

Device Problems Break (1069); Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem Injury (2348)

Event Date 03/28/2017

Event Type  Injury  

Manufacturer Narrative

Device not returned for evaluation.

Event Description

Spontaneous, consumer, serious.(b)(4).

• 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 ; 425 privet road; horsham, PA 19044 ; 2155913000
• MDR Report Key: 6526812
• MDR Text Key: 73893034
• Report Number: 3002807615-2017-00002
• 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: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• 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 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