MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION I.V. ADMINISTRATION SETS WITH CONTROL-A-FLO REGULATOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number EMC7109

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the tubing of two (2) female luer lock adapters with control-a-flo were damaged.The damage was specified as a cut in the tubing.This was identified prior to use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: only (1) actual sample was received for evaluation.Visual inspection was performed which observed a small cut on the tubing.A functional testing was performed which revealed a leak on the affected area.The reported condition was verified.The cause of the condition was due to the set left protruded while loading it into the blister cavity which resulted in a cut by the blade machine during the packaging step of the manufacturing process.The other sample was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.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: I.V. ADMINISTRATION SETS WITH CONTROL-A-FLO REGULATOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10169569
• MDR Text Key: 195704331
• Report Number: 1416980-2020-03446
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/21/2020

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: EMC7109
• Device Lot Number: 18E13T437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 07/08/2020
• Supplement Dates FDA Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.