MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7106-24

Device Problems Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)

Patient Problem Headache (1880)

Event Type  malfunction  

Event Description

Information was received indicating that a smiths cadd extension set leaked at the filter while the patient was being treated with veletri.To resolve the issue the patient immediately replaced the extension set in order to resume therapy.The patient reported having headaches, and a cutaneous flush at the patient face was noted.Such side effects are indicative of an insufficient dosage.

Manufacturer Narrative

Additional information: concomitant medical products: one cadd extension sets was returned for analysis.The sample consist of thirty-six products from p/n (b)(4) l/n 3667097.One of the returned samples was received in used conditions inside a plastic bag without its original sealed packaging; while the other thirty-five were received unused inside a plastic bag with their original sealed packaging.The sample was visually inspected at a distance of 12" to 16" under normal conditions of illumination.Delamination was found in most of the joins of the filter with the tube.The first sampled tested was the used sample received and testing was performed using hydrostat vessel to look for unusual functions and a leak was observed fleeing from the air vent of the filter in the sample used which confirmed the defect reported by the customer.Further investigation was implemented to determine the root cause.The problem source of the reported problem is unknown.

• Brand Name: CADD EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8897264
• MDR Text Key: 154435196
• Report Number: 3012307300-2019-03987
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586023279
• UDI-Public: 10610586023279
• Combination Product (y/n): N
• PMA/PMN Number: K974013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

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: Other
• Device Expiration Date: 07/19/2023
• Device Catalogue Number: 21-7106-24
• Device Lot Number: 3667097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 10/20/2019
• Supplement Dates FDA Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1