MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUMSET, PE LINED TUBING, 107 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142480489
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The incident involved a primary plumset, pe lined tubing, 107 inch on an unspecified date.It was reported that the tubing connection came apart.The tubing was infusing with saline connected to diluadid patient controlled analgesia (pca).The tubing separation/disconnection occurred at least an hour into infusion.There was no blood loss or bleed back.All tubing was replaced.The set-up was with pe lined tubing y connected to pca tubing into a peripheral iv.There was patient involved but no patient harm reported.
Additional Manufacturer Narrative
The device has been requested to be returned for evaluation; however, it has not yet been received.E1: (b)(6).
Additional Manufacturer Narrative
Received one (1) used 142480489 primary plumset on 9-nov-2023 for inspection.The tubing was separated from the secure lock male adaptor.Examination of the bond showed the tubing remained bonded inside of the port and the tubing was torn apart.The tubing was thinner at the separation, typical of a pulling force.The reported complaint can be confirmed.The probable cause is due to an unintentional pulling force during use.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY PLUMSET, PE LINED TUBING, 107 INCH
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18085121
• Report Number: 9615050-2023-00608
• Device Sequence Number: 7823186
• Product Code: FPA
• UDI-Device Identifier: 10887787006183
• UDI-Public: (01)10887787006183(17)251001(10)9405818
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K141789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2025
• Device Catalogue Number: 142480489
• Device Lot Number: 9405818
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DILUADID, MFR UNK.; PCA TUBING, MFR UNK.
• Patient Sex: Unknown