MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2C6227

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

Lot #: the reported lot is r20e18114.Initial reporter address: (b)(6).Device manufacturer address 1: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the tubing of the extension set "burst" when injected with contrast.The set was connected to the power injector syringe.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Correction to the previously submitted h4 and h10.H4: the lot was manufactured on 05/20/2020, previously submitted as 05/19/2020.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation (previously submitted as the device was received for evaluation).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the device was received for evaluation.During visual inspection of the provided photograph, the tubing was observed burst.Per the reporter, the extension set was used in conjunction with a power injector syringe.The reported condition was verified.Power injector devices are not approved to be used with the extension set.The cause of the condition could not be determined; however, the most probable cause was due to the end user operating the device with the non-approved power injector syringe.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: EXTENSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10541381
• MDR Text Key: 207171460
• Report Number: 1416980-2020-05743
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• PMA/PMN Number: K142011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2020

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
• Device Operator: Other
• Device Catalogue Number: 2C6227
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 10/21/2020; 10/27/2020
• Supplement Dates FDA Received: 10/23/2020; 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONTRAST; POWER INJECTOR SYRINGE; CONTRAST; POWER INJECTOR SYRINGE