MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. DELTEC NDL, GRIPPER PLUS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-2764-24
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during removal of the needle part of the device detached.The needle was removed by pulling the thread.There was a potential blood contamination for the staff.There were no patient harm or adverse events reported due to this event.
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 reportable information becomes available.
Additional Manufacturer Narrative
D4 - expiration date, d4 - primary udi number and h4 - device mfg date: correction.H6.Investigation codes: updated.Investigation summary: the sample returned consists of one (1) incomplete set for p/n: 21-2764-24.The returned sample was received in used condition, in a plastic bag.The returned sample was visually inspected without magnification at 12¿ to 16¿ and normal conditions of illumination.Returned sample was unable to perform any test.Per the partial returned sample, it was observed that it was in used condition, and it was not able to perform any functional test on it, the complaint could not be replicated or confirmed.The failure mode of "a0160 - difficult to remove" could not be confirmed or replicated.Other analysis can´t be performed since what was received was a partial set.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: DELTEC NDL, GRIPPER PLUS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21324272
• Report Number: 3012307300-2025-01566
• Device Sequence Number: 8494501
• Product Code: FPA
• UDI-Device Identifier: 10610586025570
• UDI-Public: (01)10610586025570(17)290103(10)4453645
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K021999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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: 21-2764-24
• Device Lot Number: 4453645
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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 Age: 33 YR
• Patient Sex: Male