MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. LEITUNG 15 CM MIT R-VENTIL; STOPCOCK, I.V. SET

Catalog Number SN1046R

Device Problems Fluid/Blood Leak (1250); Connection Problem (2900)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/22/2021

Event Type  malfunction  

Manufacturer Narrative

The device has been received for evaluation, however, testing is not yet complete.

Event Description

The event involved a leitung 15 cm mit r-ventil.It was reported that the system was set up on friday (b)(6) 2021 and on (b)(6) 2021 it was noted, during patient infusion, that the port/injection site on the umbilical artery catheter had broken/popped halfway out.It was reported that there was an unspecified amount of blood loss via the port that required a blood transfusion.The patient was reported to have returned to baseline condition.The patient¿s gender was reported as w and birth year (b)(6).There were no defects noted before use.And it was reported that the port was not used by the clinicians.The device was changed out or replaced with no further problems encountered.No other information is available at this time.

Manufacturer Narrative

One new list# sn1046r, leitung 15 cm mit r-ventil.Lot# 3660012 was received along with one used b|braun syringe 50 ml, one list# 011-h3109, 173 cm (68") smallbore ext set w/4-way stopcock w/ microclave® clear, 0.2 micron positive filter, clamp, luer lock.Lot# unknown; one used list# sn1046r, leitung 15 cm mit r-ventil.Lot# 3660012 and one used stopcock, manufacturer unknown.All devices were visually inspected.As received, the one used list# sn1046r set was found with the injection port septum dislodged from the port.The septum appeared to have been punctured and accessed with a needle.The injection port heat stake on each sample appeared to be fully formed.No other damage or anomalies were identified.The new sample was functionally tested and met product performance specifications.The injection port septum remained in place during testing.The reported complaint can be confirmed on the one used sample returned.However, how the septum became dislodged from the injection port is unknown.A device history review of 3660012 was performed and relevant commodities were reviewed; no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: LEITUNG 15 CM MIT R-VENTIL
• 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: 11675385
• MDR Text Key: 250424244
• Report Number: 9617594-2021-00127
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619049416
• UDI-Public: (01)00840619049416(17)210401(10)3660012
• Combination Product (y/n): N
• PMA/PMN Number: K082836
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Catalogue Number: SN1046R
• Device Lot Number: 3660012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3 WAY TAP, BIONECTEUR, MFR UNK; GLUCOSE, MFR UNK; HEPARIN, MFR UNK; NATRIUM KALIUM, MFR UNK; PERFUSOR, ICU MEDICAL; UMBILICAL CATHETHER, MFR UNK; UNSPEC SYRINGE, MFR UNK