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

Catalog Number	96005
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were insects mixed in the packing tape of the cosmetic box.There was no patient involvement.
Additional Manufacturer Narrative
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 information becomes available.
Additional Manufacturer Narrative
H3: one device was received for analysis.Visual inspection of the device confirmed the customer issue as an insect was found between the layers of the tapes affixed on the carton.The root cause of the issue was when affixing a product label to the carton, the operator failed to detect this issue because he was not paying close attention to the appearance of the carton.The event was shared with all the related operators twice and issued a reminder to raise awareness.Also, we reminded them to conduct visual checks thoroughly to detect any foreign substances adhering to cartons without fail.

• Brand Name: JELCO SAF-T HOLDER W/LUER ADAPTER
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21973103
• Report Number: 3012307300-2025-05267
• Device Sequence Number: 12580934
• Product Code: JKA
• UDI-Device Identifier: 00351688065592
• UDI-Public: (01)00351688065592(17)290717(10)AJ240606
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K923090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2025

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: 96005
• Device Lot Number: AJ240606
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2024
• 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