MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. EXT SET TUBING PUR AMBRATE, SPIKE, Y-CLAVE, LUER CHECK VALVE; STOPCOCK, I.V. SET

Catalog Number 011-H1225

Device Problem Fluid/Blood Leak (1250)

Patient Problems Headache (1880); Nausea (1970); Chemical Exposure (2570)

Event Date 12/16/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been received.When device becomes available, a supplemental report will be submitted.

Event Description

The customer reported that an extension set was broken (right before the bifurcation) and leaked busulfan.The pharmacist assistant inhaled the drug and left the operation to receive medical assistance due to migraine and nausea.The patient had to stay in the emergency service for observation for 12 hours.The patient is recovering but is still under the observation.

Manufacturer Narrative

Date returned to mfg: 3/6/2019.A used sample was returned for investigation with the tubing broken between the y-clave and the spike.Subsequent investigation revealed that the broken tubing between the y-clave and spike was too short and outside prescribed dimensional expectations.The probable cause of the tube breakage is bond of incorrect tube length during manual assembly.

Manufacturer Narrative

Correction to investigation.The break interface matches each separated piece suggesting there is no additional length of tubing missing at the break.Visual examination of the area around the tube break did not reveal any anomalies that would have contributed to the tube breakage.The complaint was verified; however, the probable cause of the tube breakage cannot be determined.

Manufacturer Narrative

Concomitant medical products (date returned to manufacturer): 1/18/2019.A single new administration set was returned for investigation.There were no visual defects or anomalies observed.The set was leak tested under pressure and no leakage was observed at any location along the fluid path.The complaint was confirmed based on the photograph provided; however, no probable cause of the tube crack/partial break could be determined.A lot review was performed and there were no issues found.

• Brand Name: EXT SET TUBING PUR AMBRATE, SPIKE, Y-CLAVE, LUER CHECK VALVE
• 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: 8246452
• MDR Text Key: 133074048
• Report Number: 9617594-2019-00008
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Public: (01)(17)220801(10)35036081
• 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,Followup,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2022
• Device Catalogue Number: 011-H1225
• Device Lot Number: 3503608
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BUSULFAN.; IRINOTCAN.; MITOXANTRONE.; MULTI-THERAPY EXTENSION SET.; PHOTOPROTECTOR SET.; SALINE SOLUTION.; VINCRISTINE.
• Patient Outcome(s): Hospitalization
• Patient Age: 25 YR