MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SET; SET, ADMINISTRAION, INTRAVASCULAR

Model Number	21-7395-24
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a customer had an incident whereby the tubing cracked open in the middle of the set, not near any connection.The patient was home and it happened overnight while he was sleeping.Not sure of the cause.The reporter had no other complaints and we haven't seen anything like this before.The patient was not harmed and treatment was not delayed.We are unsure of how long the tubing was leaking so we have no way of knowing how much of the medication was lost and not administered to the patient.No patient injury was reported.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
Other, other text: the sample returned, was received without its original packaging, in used condition, and decontaminated.The complaint returned units were visually inspected under normal conditions of illumination according to procedure no obstructions or other defects were detected in either of the joins of the product are visible.The tube presents a slit.The reported failure mode is confirmed.Production personnel wipes the excessive solvent from inside diameter of tube to prevent occlusion or hourglasses.Production personnel turn tube back and forth for a minimum of two seconds.Remove immediately after two seconds with a maximum of 5 seconds in the solvent according to procedure.Production performs 100% visual inspection to assure that that tubing does not display excessive solvent.Production performs a delivery accuracy test to (b)(4) units at shift start up, the end of every shift, the beginning of every job, the end of every job; a new lot of materials components or equipment adjustment.Quality personnel takes a sample of fifteen units every two hours, prior to placing product in bag, verify that tubes are not occluded, tubes are not kinked or coiled too tightly, tubes shall not have flat spots, or other damage.The proper performance of the tests and that the results are within specification.Root causes cannot be associated with the manufacturing process.Device history record review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRAION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16060878
• Report Number: 3012307300-2022-28201
• Device Sequence Number: 12433999
• Product Code: FPA
• UDI-Device Identifier: 10610586027543
• UDI-Public: 10610586027543
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2023

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: Health Professional
• Device Expiration Date: 01/17/2024
• Device Model Number: 21-7395-24
• Device Catalogue Number: 21-7395-24
• Device Lot Number: 3757210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2022
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male