MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 81 CM (32") APPX 5.1 ML, 20 DROP BLOOD SET W/200 MICRON FILTER, SPIN LUER, BAG H; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 011-C6028

Device Problem Material Separation (1562)

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

Event Date 09/13/2023

Event Type  malfunction  

Manufacturer Narrative

Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.

Event Description

It was reported that a transpac safeset experienced a separation.The reporter stated, ¿the connection between the drip chamber and the line falls apart during infusion".The event occurred during infusion.The event does not involve death or serious deterioration of a person and no one was harmed as a result of the reported event.The solution/drug involved was normal saline and came into contact with the patient or healthcare provider.There was no impact except for cleaning and a short delay.Normal cleaning followed as it did not require chemo spill cleaning.There was no patient harm reported.

Manufacturer Narrative

Two used 011-c6028 blood sets were returned with the tubing separated at the bond to the distal end of the blood filter.The male bond post at the distal end of the blood filter was bent in both assemblies that were returned suggesting external forces were applied.The bonds had adequate solvent applied at the bond interface that separated.The tubing was measured and met design expectations.The probable cause is typical of unintentional pulling forces applied during use.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 11/16/2023.

• Brand Name: 81 CM (32") APPX 5.1 ML, 20 DROP BLOOD SET W/200 MICRON FILTER, SPIN LUER, BAG H
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17927568
• MDR Text Key: 326365528
• Report Number: 9617594-2023-00826
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840619004699
• UDI-Public: (01)00840619004699(17)260201(10)5206407
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K983559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-C6028
• Device Lot Number: 5206407
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2021
• 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: NORMAL SALINE, MFR UNK