MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 41 CM (16") PUR BIFUSE CLEAR/YELLOW ADD-ON SET W/MICROCLAVE®, DRY SPIKE ADAPTER,; STOPCOCK, I.V. SET

Catalog Number 011-H3362-10

Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it has not yet been received.

Event Description

The event involved a 41 cm (16") pur bifuse clear/yellow add-on set w/microclave®, dry spike adapter, 10 units that was reported to exhibit breakage during the percussion of the two paths with the icu administration device by the infusion pump tubing at approximately 03h3min pm.The tip of the spike broke and remained in the icu medical device, forcing the nurses to bring the bags back to the pharmacy to have the icu device changed out under the hood (isolator where cytotoxic drugs are prepared).Several drugs were used with this product.Information pertaining to this event was communicated by a call of the nurses to the service in charge of changing the icu device.When the device broke, the icu device contained only nacl 0.9% or g5% as a solvent.A procedure of exchanging out lot numbers is ongoing.There was no patient involvement, no adverse events/human harm.However, there was a delay in therapy as it was not possible to administer the treatment to the patient at the time of the event.This captures the second of three events reported at different healthcare services.

Manufacturer Narrative

The customer provided the following for investigation: one used return unit of 41 cm (16") pur bifuse clear/yellow add-on set w/microclave®, dry spike adapter, 10 units; lot #5499160.One used list #unknown, infusion set; lot #unknown.As received, there was an unknown piercing pin broken off inside the dry spike adapter.The piercing pin was stuck and could not be removed using normal handling.However, the broken off piercing pin would not flow down the line of the fluid path.The complaint of broken piecing pin inside adaptor was confirmed on the used returned unit.However, there is no indication that loose foreign material within the fluid path would result in release of foreign material into the body of a patient based on the results of the investigation.The dry spike adapter met product design specification and there were no damages or anomalies that would lead to the stuck piercing pin.The probable cause of the stuck unknown piercing pin is unknown.D9: date returned to mfg: 10jan2022.

• Brand Name: 41 CM (16") PUR BIFUSE CLEAR/YELLOW ADD-ON SET W/MICROCLAVE®, DRY SPIKE ADAPTER,
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 13114854
• MDR Text Key: 290453200
• Report Number: 9617594-2021-00320
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619094980
• UDI-Public: (01)00840619094980(17)260701(10)5487462
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H3362-10
• Device Lot Number: 5487462
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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: INFUSION BAGS, MFR UNK; TUBING FOR INFUSION PUMP, LOT 32272371, MFR FK; UNSPECIFIED NACL 0.9% OR UNSPECIFIED G5%, MFR UNK