MAUDE Adverse Event Report: ST PAUL CADD CASSETTE RESERVOIRS - FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7301-24

Device Problem Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 05/31/2023

Event Type  malfunction  

Manufacturer Narrative

Other, other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported the disposable exhibits "a risk of leakage" at the disposable tubing near the clamp.The patient noticed a bulge bordering on rupture, and when she engaged the disposable, the device emitted a beep-type alarm with no message.Device is available for return.No credit or replacement requested.The patient did not keep the device but a photo is available.

Manufacturer Narrative

No product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.G2 email is: (b)(4).

• Brand Name: CADD CASSETTE RESERVOIRS - FLOW STOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17363076
• MDR Text Key: 319520987
• Report Number: 3012307300-2023-07323
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027215
• UDI-Public: 10610586027215
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7301-24
• Device Catalogue Number: 21-7301-24
• Device Lot Number: 4334116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Female