MAUDE Adverse Event Report: BAXTER HEALTHCARE - CARTAGO NITROGLYCERIN SET WITH DUO-VENT SPIKE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	1C8043
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).One device was received evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that 'three or four' nitroglycerin sets had separated.The ¿tubing was coming apart¿ when in use.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.Visual inspection revealed that the bushing was separated from the male luer.The insertion depth of the tube was measured and found to be within specification.Further inspection was performed on the tube and revealed the presence of solvent.The reported condition was verified.The cause of the condition was determined to be excessive solvent applied during manufacturing.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NITROGLYCERIN SET WITH DUO-VENT SPIKE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• MDR Report Key: 7638882
• Report Number: 1416980-2018-03871
• Device Sequence Number: 19453437
• Product Code: FPA
• UDI-Device Identifier: 00085412019994
• UDI-Public: (01)00085412019994
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K150860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/07/2022
• Device Catalogue Number: 1C8043
• Device Lot Number: R17F07037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1