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

Model Number 21-7052-24

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Information was received indicating that the patient was admitted to emergency following a leakage of solution from a smiths medical cadd extension set.Subsequently, the set was changed.No sign of severity was reported.

Manufacturer Narrative

Device evaluation: one sample was returned for analysis in used condition without its original packaging.Functional testing involved a leak test and showed that leaking was present at the air vent of the filter.A review of manufacturing processes was performed.It was verified that procedures in the assembly process and quality check process were being properly followed.The investigation determined that silicon oil being transferred from syringes and/or vials into the medication reservoir during filling by the customer was the cause of the reported issue.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: CADD
• 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11337406
• MDR Text Key: 232173069
• Report Number: 3012307300-2021-01288
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586020346
• UDI-Public: 10610586020346
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K974013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 21-7052-24
• Device Catalogue Number: 21-7052-24
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/19/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Other