MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PLUM BURETTE CLAVE SITES 114IN NDEHP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1427329

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/21/2021

Event Type  malfunction  

Manufacturer Narrative

The device has been requested to be returned for evaluation.The device has not been received.

Event Description

The event involved a plum burette where it was reported that ¿a hair was observed in the cassette¿.The event was noted during priming.There was no patient involvement and no patient harm.

Manufacturer Narrative

Received one used plum 150 ml burette set, clave injection site, 2 clave y-sites, sl, 114in.As received, the set was visually inspected and the hair was confirmed to be inside of the cassette, in the fluid path.The customer returned an image appearing to show a hair in the cassette.No other anomalies were found.The complaint can be confirmed.The probable cause is due to an error during the gowning process.The device history review (dhr) could not be performed as the lot number was not provided.Additional information: d9 - date returned to mfg is 11/30/2021.

• Brand Name: PLUM BURETTE CLAVE SITES 114IN NDEHP
• 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: 12811209
• MDR Text Key: 284899960
• Report Number: 9615050-2021-00162
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1427329
• Device Catalogue Number: 142730490
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2022
• 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