MAUDE Adverse Event Report: ICU MEDICAL ASD, INC. JELCO SAF-T HOLDER MULTI SAMPLE LUER ADAPTER; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	96004
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that a vacutainer was attached to the clear link on the arterial line tubing for a blood draw.The sst and green-top tubes filled without issue.When the cbc (purple-top) tube was inserted into the vacutainer, it filled only approximately one-quarter of the tube.A ptt (blue-top) tube was then inserted, at which time the registered nurse heard a burst of air.Immediately following the sound, blood was observed leaking around the connection site.The vacutainer was promptly removed.Upon inspection, a portion of the vacutainer was noted to be enlarged and broken, with the broken piece visualized inside the clear link.
Additional Manufacturer Narrative
D9: date returned to mfg.: 1/6/2026.H3 and h6.Codes: updated.Device evaluation: three new products and two used products were returned for evaluation.As received, the used saf-t holder luer was observed to be broken including the male luer taper being broken off from the connector.A crack was also observed on the luer body of the returned used mating device.The new samples show no damage or anomalies.No other damage or anomalies were observed.To replicate clinical use, simulated blood was drawn from a beaker using a ¿bd vacutainer¿ inserted into the saf-t holder device.No leaks were observed during use on the three new samples returned.The complaint of leakage was confirmed, and the probable cause was due to luer damage.The complaint of damage/breakage can be confirmed, and the probable cause was due to an environmental stress condition where insufficient drying of the disinfectant on the luer connector can cause plastic deformation when connected.A device history record review could not be performed as the lot number was unknown.

• Brand Name: JELCO SAF-T HOLDER MULTI SAMPLE LUER ADAPTER
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): ICU MEDICAL ASD, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23896514
• Report Number: 3012307300-2025-13768
• Device Sequence Number: 20165998
• Product Code: JKA
• UDI-Device Identifier: 00351688065585
• UDI-Public: (01)00351688065585
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K923090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: 96004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown