MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. CADD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7022-24

Device Problems Infusion or Flow Problem (2964); Air/Gas in Device (4062)

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

Event Date 02/13/2024

Event Type  malfunction  

Event Description

It was reported that during use, the line had air bubbles and no liquid was visible.The line was primed with gravity and a chemolock spiros was used and attached at the end of the line during the infusion.Reservoir volume 13.9ml; continuous infusion rate 4ml/hr; total volume on label 184.96ml; total given 174.15ml.Per the reporter, there were no adverse patient effects.

Manufacturer Narrative

H3: device not received by manufacturer.No product was returned.The reported complaint could not be confirmed.If the product is returned this complaint will be reopened for further investigation.No lot number was provided; therefore, a history record review could not be conducted.

• Brand Name: CADD ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18936991
• MDR Text Key: 338312968
• Report Number: 9617604-2024-00240
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586019791
• UDI-Public: 10610586019791
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K895046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/18/2024

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 Operator: Lay User/Patient
• Device Catalogue Number: 21-7022-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/19/2024
• 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
• Treatment: CADD-SOLIS VIP AMBULATORY INFUSION PUMP; CHEMOLOCK SPIROS