MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" SMALLBORE EXT SET W/CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Model Number B1415

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 07/19/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to return for evaluation.It has not been received.

Event Description

The event involved a patient in the neonatal intensive care unit (nicu), with 7¿¿ smallbore extension set w/clamp, rotating luer where a crack was noted at the hub of the extension set resulting in blood leaking quite extensively during an arterial line setup change.The tubing set was connected to an unknown extension set.The blood loss was not able to be quantified, but no medical intervention was required and no patient harm was reported.

Manufacturer Narrative

D10 - date returned to mfg - october 15, 2020.H10 - one used list# b1415, 7" smallbore ext set w/clamp, rotating luer (lot# unknown) was received and visually inspected.As received, a single axial crack on the female luer adaptor of the extension set was identified.No additional damage or anomalies were found.No mating devices were returned.The reported complaint can be confirmed.The probable cause of the cracked luer and subsequent leakage cannot be determined.A device history review lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 7" SMALLBORE EXT SET W/CLAMP, ROTATING LUER
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 10601636
• MDR Text Key: 209029429
• Report Number: 9617594-2020-00424
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• 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: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B1415
• Device Catalogue Number: B1415
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPEC EXTENSION SET, MFR UNK; UNSPEC EXTENSION SET, MFR UNK