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

Catalog Number	21-3271-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was with the device there was a suspected leakage.There was patient involvement, and no patient harm/adverse event reported.
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
H6: unknown.H3: one sample was returned.Sample was visually and functionally tested and the customer reported problem was able to be confirmed.The sample was leaking at a broken base part.Since the sample was returned in used condition, the root cause cannot be attributed to the manufacturing process.A root cause was unable to be determined.The reported failure mode will continue to be monitored and if a trend is identified an investigation will be opened.A dhr review was unable to be completed as no lot was provided.

• Brand Name: DELTEC GRIPPER MICRO
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20452724
• Report Number: 9617604-2024-00798
• Device Sequence Number: 7007970
• Product Code: FPA
• UDI-Device Identifier: 10610586029882
• UDI-Public: (01)10610586029882
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: 21-3271-24
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 05/13/2025
• 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