MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX PRESSURE INFUSION C-FUSOR; INFUSOR, PRESSURE, FOR I.V. BAGS

Catalog Number MX4810P1CZ

Device Problem Leak/Splash (1354)

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

Event Date 01/01/1901

Event Type  malfunction  

Event Description

It was reported that air escapes from the bag and is therefore leaking, no injury occurred.

Manufacturer Narrative

One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.Dhr review was done, no issues related to the original complaint were found.

Manufacturer Narrative

Other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problem or issues were identified during the device history record review.Two samples were received for evaluation.Visual inspection shows some signs of damage - scratches on the cuff which may correspond to use of the product, crumpled tubing from forceps usage, broken pressure gauge without coverslip (probably caused by improper use).The functional test was performed as per procedure on the samples.Product was inflated to 300mm hg and the c-fusor kept the pressure for 2 minutes.Both samples stayed inflated, no leaking from the bag was observed.Based on the investigation results we cannot confirm reported issue.The customer requested a second evaluation on the products.Products were inflated to 300mm hg and hung up for observation.After about thirty minutes, the pressure began to drop slightly for sample with lot no.3541453.After two hours, a pressure drop of about 50 mm hg was observed for lot no.3541453.No pressure drop was observed for the sample with lot no.3967557.Another testing of the sample with lot no 3541453 was performed.To identify the place of leakage, the inflated sample was put in the water.Leakage was observed between luer lock male and stopcock.These two parts are joined manually by tightening.However, even after proper tightening, the leakage was still observed.Based on the investigation results we confirm reported issue for the sample with the lot no.3541453.No similar customer complaints were identified.We considered this issue as an isolated incident, probably caused by material fatigue.Root cause is unknown.

• Brand Name: MEDEX PRESSURE INFUSION C-FUSOR
• Type of Device: INFUSOR, PRESSURE, FOR I.V. BAGS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 13367391
• MDR Text Key: 284531805
• Report Number: 3012307300-2022-01918
• Device Sequence Number: 1
• Product Code: KZD
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

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: Health Professional
• Device Catalogue Number: MX4810P1CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/13/2021
• Initial Date FDA Received: 01/27/2022
• Supplement Dates Manufacturer Received: 05/03/2023
• Supplement Dates FDA Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1