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

Model Number 1427329

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned; however it has not yet been received.

Event Description

The event involved a plumset that was reported to have a small amount of taxotere leakage on the bottom burette during infusion.The healthcare provider immediately stopped infusion and changed to another plumset.There was patient involvement and no harm reported.

Manufacturer Narrative

H10 - one used list #(b)(4), plum 150 ml burette set, clave injection site, 2 clave y-sites, sl, 114in; lot #4737028 and one used unknown list #, bag spike adapter with spiros; lot #unknown were received.A customer-provided photo showing the location of the leak at the bottom of the burette was reviewed.The complaint of leakage on the (b)(4) plum burette set can be confirmed.The set was leak tested per product specification.There was a leak observed from the base of the burette.The leak occurred between the plastic cylinder of the burette and the bottom cap of the burette.There appeared to be insufficient solvent coverage leading to the leak observed.The probable cause of the leakage is due to insufficient solvent being applied during the manufacturing location.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D10 - date returned to mfg - january 4, 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
• MDR Report Key: 11096168
• MDR Text Key: 225303079
• Report Number: 9615050-2020-00280
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787008804
• UDI-Public: (01)10887787008804(17)230401(10)4737028
• Combination Product (y/n): N
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: 1427329
• Device Catalogue Number: 142730490
• Device Lot Number: 4737028
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BAG SPIKE ADPTR W/SPIROS, MFR ICU MED,UNK LIST/LOT; TAXOTERE, UNK MFR