MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 81 CM (32") APPX 5.1 ML, 20 DROP BLOOD SET W/200 MICRON FILTER, ROTATING LUER, B; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 011-C6028

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation.Without the returned device a probable cause cannot be established.

Event Description

The event occurred on an unknown date.The event involved a drop blood set w/200 micron filter, rotating luer, bag hanger that the customer reported an unspecified chemotherapy leaked from secondary giving set causing a large chemotherapy spill.The secondary giving set tubing fell away from the count chamber allowing chemotherapy to spill to the floor.The chemotherapy spill was managed by the nursing staff per local area procedure.The patient's drug had to be made and re-issued from the pharmacy.The outcome has no apparent injury to patient or staff but the staff may have been exposed to the chemotherapy drug during the large spill clean up.There was patient involvement, however no report of patient harm.

Manufacturer Narrative

H10: received one new list # 011-c6028, 81 cm (32") appx 5.1 ml, 20 drop blood set w/200 micron filter, rotating luer, bag hanger; lot # 4040339 on october 1, 2019 in salt lake city for investigation.The set was received in a sealed package.No damage or anomalies were identified on the packaging.The set was removed from the packaging and inspected.No damage or anomalies were identified on the set.The set was leak tested and passed the product performance specification.No leakage was observed.The complaint of leakage could not be confirmed.A device history review (dhr) lot #4040339 review was conducted and there were no non conformances found that would have contributed to the reported complaint.

• Brand Name: 81 CM (32") APPX 5.1 ML, 20 DROP BLOOD SET W/200 MICRON FILTER, ROTATING LUER, B
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• 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: 9106674
• MDR Text Key: 198333965
• Report Number: 9617594-2019-00312
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840619004699
• UDI-Public: (01)00840619004699(17)240301(10)4040339
• Combination Product (y/n): N
• PMA/PMN Number: K983559
• 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: 09/06/2019

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: 03/01/2024
• Device Catalogue Number: 011-C6028
• Device Lot Number: 4040339
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 09/23/2019
• Supplement Dates Manufacturer Received: 10/17/2019
• Supplement Dates FDA Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1