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

Catalog Number	21-2737-24
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: one sample was received.No damage or defects were found during a visual inspection.During the functional test it was detected that the distilled water did not pass through the sample.The sample returned was occluded.According to the functional test, the failure mode was confirmed.No non-conformances were found during the dhr review.
Event or Problem Description
It was reported that the device could not prime and it was blocked.This occurred during priming at the facility.There was no patient involvement and no patient harm/adverse event reported.There was no disinfection or sterilization, and no infectious disease occurred since unopened and unused.

• Brand Name: DELTEC GRIPPER NEEDLES
• 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20080388
• Report Number: 9617604-2024-00676
• Device Sequence Number: 7598706
• Product Code: FPA
• UDI-Device Identifier: 10610586023200
• UDI-Public: (01)10610586023200(17)280925(10)4426777
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K870866
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2024

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: 21-2737-24
• Device Lot Number: 4426777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• 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
• Patient Sex: Unknown