MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE® CLEA; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 12514-01

Device Problem Break (1069)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

The device has been received for evaluation, however, investigation is not yet complete.

Event Description

The event occurred on an unspecified date and involved a 7" (18 cm) appx 0.45 ml, pressure infusion (400psig) ext set w/ microclave® clear, purple clamp, rotating luer.The customer reported that the device was breaking and medication cannot be pushed through.There was unknown patient involvement; harm was not reported as a consequence of this event.

Manufacturer Narrative

Received two used list #12514-01, 7" (18 cm) appx 0.45 ml, pressure infusion (400psig) ext set w/ microclave¿ clear, purple clamp, rotating luer; lot #13838870 - no visual damages or anomalies were observed.Also received one used list #unknown, baxter one-link needle-free iv connector; lot #ur22d29093.Non icu product connector.Also received one used used.List #unknown, dr.(b)(6) naloxone hydrochloride injection, usp 2mg/2ml single dose syringe; lot #k230695.Also received one new list #unknown, auromedics naloxone hydrochloride injection, usp 2mg per 2 ml single-dose disposable prefilled syringe; lot #3nx23006.Found a broken microclave tip in syringe.The broken microclave was not returned.The 2 list #12514-01 were primed and leak tested.Both sets primed without any issues.No leaks were observed.Measured the internal diameter of the received syringes.Dr reddy: 0.045" auromedics couldn't be measured due to broken tip.The reported complaint of breaking could be confirmed.A syringe was returned with a broken microclave tip.The probable cause is from the use of an incompatible mating device.The directions for use states: the clave connector is compatible with luers with an internal diameter between 0.062¿ and 0.110." the lot history of the provided packaging was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE® CLEA
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 18617735
• MDR Text Key: 334500493
• Report Number: 9617594-2024-00078
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

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: 12514-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/31/2024
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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