MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 122" 15 DROP PRIMARY SET W/REMV 3 GANG 4-WAY STOPCOCKS, CLAVE¿, ROTATING LUER, 2; STOPCOCK, I.V. SET

Catalog Number B9784

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.

Event Description

The event involved a 122" 15 drop primary set w/remv 3 gang 4-way stopcocks, clave¿, rotating luer, 2 ext.The report states that they had experienced experienced a break, resulting in a leak.They noticed the manifold on b9784 was compromised.It was also reported that the product was different than what they were accustomed to receiving from icu medical.The material used to make the manifold, which holds multiple stopcocks, felt much cheaper, thinner, and flimsier.This had caused multiple items, still packaged inside the icu medical box, to be bent and cracked.The leak happened next to the bed side.They noticed liquid leaking and then went to check all other product from that same lot and case.They then noticed other eaches inside the case were also damaged (bent and/or cracked).The event occurred during patient use.The product was not reprocessed or re-sterilized prior to use.Here was patient involvement and no human harm nor adverse event, there was a delay in therapy reported.This is the fifth of five events reported.

Manufacturer Narrative

A series of photos were shared by the customer, basically is observed a pieces break from a bent force applied.No additional damage was observed on the photos.One (1) used sample #b9784 was returned for evaluation.As received it was confirmed a broken part from the manifold section, it was confirmed based on the item configuration that broken unions were bonded.The complaint of leaks can be confirmed based on the physical used sample evaluation.The probable causes was due to an unintentional twisting force applied during use.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 122" 15 DROP PRIMARY SET W/REMV 3 GANG 4-WAY STOPCOCKS, CLAVE¿, ROTATING LUER, 2
• 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
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18275074
• MDR Text Key: 329840759
• Report Number: 9617594-2023-01082
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B9784
• Device Lot Number: 13730508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED LIQUID, UNKNOWN MFR