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

Model Number 1205328

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 07/13/2019

Event Type  malfunction  

Manufacturer Narrative

The customer indicated that the device is available to return for investigation; it has not been received.

Event 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".

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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 8887812
• MDR Text Key: 154146556
• Report Number: 9615050-2019-00351
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005209
• UDI-Public: (01)10887787005209(17)190901(10)69194NS
• Combination Product (y/n): N
• PMA/PMN Number: K142974
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/13/2019
• Supplement Dates Manufacturer Received: 08/20/2019
• Supplement Dates FDA Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1