MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 100" (254 CM) APPX 12.8 ML, 15 DROP PRIMARY SET W/3 MICROCLAVE®, ROTATING LUER,; STOPCOCK, I.V. SET

Catalog Number B9126

Device Problem No Flow (2991)

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

Event Date 10/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been requested to be returned for evaluation; however, it has not yet been received.Additional contact: (b)(4).

Event Description

The incident involved a 100" (254 cm) appx 12.8 ml, 15 drop primary set w/3 microclave®, rotating luer, filter cap on an unknown date.As per report, a syringe pump tubing was connected to the proximal site with propofol during infusion.At the same time, the anesthesiologist injected the propofol bolus at the 2nd site during induction.The propofol immediately moved up to the solute so, they had to clamp the tubing to ensure that the medication was directed to the patient.Once the patient was induced, they injected the antibiotic via the distal site and the same problem occurred (i.E.A return to the solute).The primary solute was connected to a 20g gauge peripheral permeable channel.It should be noted that the problem was not repeated with subsequent injections.The continuous infusion of propofol did not flow back to the solute at any time either.There was patient involvement and no adverse event reported.

Event Description

Update received where the customer reported that the involved product was a rimary set, 3 clave y-sites, 100 inch, non-dehp with list number: b91260490 and with lot number: 13539745.

Manufacturer Narrative

The complaint could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history report (dhr) for lot: 13539745 was reviewed and no non conformities were found that would have led to the reported complaint.

• Brand Name: 100" (254 CM) APPX 12.8 ML, 15 DROP PRIMARY SET W/3 MICROCLAVE®, ROTATING LUER,
• Type of Device: STOPCOCK, I.V. SET
• 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: 18105754
• MDR Text Key: 329119223
• Report Number: 9617594-2023-00963
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709013025
• UDI-Public: (01)00887709013025(17)260301(10)13539745
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K142367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2024
• 2 Devices were Involved in the Event: 1 2

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: B9126
• Device Lot Number: 13539745
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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: PROPOFOL, UNK MFR.; UNSPECIFIED ANTIBIOTIC, MFR UNK.; UNSPECIFIED SYRINGE PUMP TUBING, MFR UNK.