MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1468728

Device Problems Difficult to Insert (1316); Failure to Infuse (2340); Device-Device Incompatibility (2919)

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

Event Date 04/02/2023

Event Type  malfunction  

Event Description

A user facility mandatory medwatch (mw5116469) was received that stated, ¿we had a nurse complain of not being able to push the following atropine syringes (ndc 16729-484-03 manufactured by accord) through our standard icu medical iv tubing (list no 14687-28 primary plum set).They were able to withdraw contents into another syringe and administer.They did not report any adverse outcome because of this, but it certainly has the potential to cause delays¿.Additional event information obtained from the medwatch report: the device medical problems are device difficult to setup or prepare, device-device incompatibility and no flow.There was no harm reported.

Manufacturer Narrative

It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not yet been received.Without the returned device, a probable cause is unable to be determined.

Manufacturer Narrative

Additional information can be found in sections b5, d4, d9, h2, h3, h4 and h6.

Event Description

The customer provided the following updated information to the complaint record: the (glass) ¿syringes do not seem compatible with our tubing.I'm assuming this may apply to all of these type accord syringes with smaller gauge hole and our icu medical tubing.Reference report: mw5116468¿.The customer further stated that the reported event/product issue did not result in any serious patient injuries, critical delay(s) and/or adverse consequences.There was no change to patient¿s baseline condition.The nurse could not push atropine from syringe into tubing.The issue seemed to be with atropine syringes.It seemed the syringe gauge size was smaller than normal, such that the tubing plugged the syringe.The customer stated that he was not certain if there was anything wrong with the tubing.It just wasn¿t compatible with those particular syringes.The customer was not certain if there was some product issue with the size of the syringe holes (gauge) or if they were manufactured as intended.The customer reported no product issue, only that these products appear to be incompatible.

Manufacturer Narrative

The following items were received from the customer: 1 used list # 146870489, primary plum set, clave secondary port, clave y-site, secure lock, 103 inch; lot #11285746.1 used unknown list #, atropine sulfate injection 10ml glass syringe; lot #m2111083.As received, stickdown was observed on the clave at the secondary port of the cassette.The male luer of the glass syringe was measured and found to be incompatible with the microclave.The reported complaint was confirmed.The probable cause is access with an incompatible mating device during use.The directions for use (dfu) states: the clave connector is compatible with luers with an internal diameter (id) between 1.55 mm and 2.8 mm.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16769928
• MDR Text Key: 313952861
• Report Number: 9615050-2023-00114
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005650
• UDI-Public: (01)10887787005650(17)251101(10)11285746
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2023

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 Model Number: 1468728
• Device Catalogue Number: 146870489
• Device Lot Number: 11285746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 04/19/2023
• Supplement Dates Manufacturer Received: 04/27/2023; 05/26/2023
• Supplement Dates FDA Received: 05/16/2023; 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2022
• 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: ATROPINE SYRINGES (NDC 16729-484-03), MFR ACCORD