MAUDE Adverse Event Report: ST PAUL CADD ACCESSORIES LOCKBOX, YELLOW; PUMP, INFUSION

Model Number	21-2189-25
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturing device history record (dhr) review request was sent to the supplier; no further information has been made available to date.The mostly likely root cause of the reported issue was crazed / cracked by lockboxes being cleaned with incompatible solutions.Please see attachments for cleaning recommendations from raw material supplier.Ifu indicates: use a soft, lint-free cloth to clean the lockbox using a mild detergent solution, and then disinfect the lockbox for a contact/kill time of 4 minutes with the product caution: using a cleaning or disinfecting product other than that listed above may damage or affect the transparency of the lockbox.
Event or Problem Description
It was reported that the plastic on all 10 of the customers lockboxes appear cracked and as if shattered'.The customer is concerned about the infection control risk of them not being fully intact and they look awful to both the customer and patients.The shattered edges can also be sharp and unsafe for the user.Ongoing issue over last 18 months.No patient injury was reported.
Additional Manufacturer Narrative
While performing a review of submitted mdr report it was discovered that this file was inadvertently assessed as reportable.No patient death, serious injury, and no evidence of a reportable product malfunction.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.File (b)(4) is no longer considered reportable, please disregard any mdr reports associated with it.

• Brand Name: CADD ACCESSORIES LOCKBOX, YELLOW
• Common Device Name: PUMP, INFUSION
• 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: 14313467
• Report Number: 3012307300-2022-07908
• Device Sequence Number: 14774002
• Product Code: FRN
• UDI-Device Identifier: 10610586035036
• UDI-Public: 10610586035036
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K080743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2022

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 Model Number: 21-2189-25
• Device Catalogue Number: 21-2189-25
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/07/2020
• 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: 03/14/2022
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0148-2022
• Patient Sequence Number: 1
• Patient Sex: Unknown