MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. MICROBORE EXTSET 5IN CLV PP-TSITE SPNCLR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	1205328
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	07/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer indicated that the device is available to return for investigation; it has not been received.
Event or Problem Description
The event involved a report stating that the extension tubing has disconnected from the microbore t connector part; it has separated from inside the connector.It was not pulled on, not damaged, it just suddenly disconnected and was attached to a central line.The baby started bleeding out of the t- connector.The event was noticed when the nurse did the rounds in nicu.There was patient involvement, and "some blood loss but nothing permanent".
Additional Manufacturer Narrative
The complaint of separation 120530480 could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.A batch record review was performed to lot# 69194ns, list# 12053-0480 and no discrepancies that may have contributed to a complaint of this nature were found.The quality inspection of final visual and physical evaluation results indicated that the product met specification requirements.

• Brand Name: MICROBORE EXTSET 5IN CLV PP-TSITE SPNCLR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 8887812
• Report Number: 9615050-2019-00351
• Device Sequence Number: 2587198
• Product Code: FPA
• UDI-Device Identifier: 10887787005209
• UDI-Public: (01)10887787005209(17)190901(10)69194NS
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K142974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2019

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: 09/01/2019
• Device Model Number: 1205328
• Device Catalogue Number: 120530480
• Device Lot Number: 69194NS
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1