MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9.5" (24 CM) 0.53 ML, SMALLBORE BIFUSE EXT SET W/NANOCLAVE¿, 3 CLAMPS, ROTATING; STOPCOCK, I.V. SET

Catalog Number	A1252
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 9.5" (24 cm) 0.53 ml, smallbore bifuse ext set w/nanoclave¿, 3 clamps, rotating luer.The customer reported that the product did not work as expected.After the peripherally inserted central catheter (picc) line was change and infusing, it was noted that the 9.5 in.Smallbore biofuse extension set w/nano-clave was leaking at the end.The tubing was in-place for about 10 minutes before a leak was detected.The leaking extension set was replaced by a quad extension set using sterile technique.The customer reported that the event occurred "at 4 nccc location." the event occurred during patient use, however, no harm was reported as a consequence of this event and no monitoring required.
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.
Additional Manufacturer Narrative
The sample was returned for evaluation.As received an unknown neutron was connected into the female luer adaptor.No additional damage or anomalies were observed the unit was primed and tested.A leak was found coming from a crack observed on the female luer adaptor was confirmed.The leak was not coming from the parting line of the sample.No additional leaks were observed.Complaint of leak can confirmed based on the used physical sample evaluation.The probable cause of the crack is typical due to environment stress cracking during use.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 9.5" (24 CM) 0.53 ML, SMALLBORE BIFUSE EXT SET W/NANOCLAVE¿, 3 CLAMPS, ROTATING
• Common Device Name: 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: 17887457
• Report Number: 9617594-2023-00811
• Device Sequence Number: 7327343
• Product Code: FMG
• UDI-Device Identifier: 00887709090231
• UDI-Public: (01)00887709090231(17)280201(10)13551638
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: A1252
• Device Lot Number: 13551638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED SOLUTION, MFR UNK
• Patient Sex: Unknown