MAUDE Adverse Event Report: ST PAUL CADD MEDICATION CASSETTE RESERVOIR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7308-24

Device Problems Break (1069); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2022

Event Type  malfunction  

Event Description

Information was received indicating a cadd cassette reservoir blue flow stop clamp was found to be broken in the packaging.No patient involvement.

Manufacturer Narrative

Other text: (b)(6).

Event Description

Information was received indicating a cadd cassette reservoir blue flow stop clamp was found to be broken in the packaging.No patient involvement.

Manufacturer Narrative

Report source: (b)(6).

Manufacturer Narrative

Other, other text: d4: lot number: 4163629.D4: expiration date: 22-jul-2026.H4: manufacture date: 09-aug-2021.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection: it was observed the blue clip broken in all samples, also the spring occlusion mechanism is broken on two of the samples received; thus the failure mode is confirmed.It was tried to replicate the failure reported, following the below steps: the blue clip was tried to be broken by pressing with force the clip using the hand.The blue clip was broken in a similar way than the returned unit.Conclusions: based on the test performed, it is concluded that the failure reported could be reproduced by pressing the clip against the cassette with force.And it can be observed that the cuts in the tested unit are like the cuts in the complainant unit.Root cause cannot be associated with the manufacturing process since blue clip in correct condition is necessary to perform the leak test inspection, there for the damage-broke of the blue clip was after the product left shm facilities.The cause of the reported problem could not be determined.Summary of dhr review: there were no relevant findings detected in the dhr.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 33012307300-2022-03800.The report was submitted in error.

• Brand Name: CADD MEDICATION CASSETTE RESERVOIR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13578198
• MDR Text Key: 285952030
• Report Number: 3012307300-2022-03800
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586032374
• UDI-Public: 30610586032374
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K081156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-7308-24
• Device Lot Number: 4163629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1