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	10/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer returned a used device for evaluation.As received an unknown neutron and a nano clave were connected into the set, additional the y-connector was observed to be broken.Complaint of leak can confirmed based on the used physical sample evaluation.The probable cause is due to unintentional bending force applied during use.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
This incident is related to 9617594-2023-00811-00 - that report stated: 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.The customer returned 2 used a1252 samples for evaluation.The date of this incident is unknown.This report reflects the second sample that was returned and failed.See section h10 for more details.

• 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: 18088354
• Report Number: 9617594-2023-00951
• Device Sequence Number: 6725917
• 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
• Report Date (Section B): 10/09/2023

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: 10/09/2023
• Initial 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