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

Catalog Number	21-3468-24
Medical Device Problem Code	Protective Measures Problem (3015)
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
H6.Investigation codes: updated investigation summary: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.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.
Event or Problem Description
It was reported that while using the device the safety device had engaged over the needle however the needle remained exposed leading to a needle stick.There was patient involvement and no harm to the patient.
Additional Manufacturer Narrative
E3 - initial reporter occupation unknown.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.

• Brand Name: DELTEC 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19774291
• Report Number: 9617604-2024-00587
• Device Sequence Number: 8181442
• Product Code: FPA
• UDI-Device Identifier: 10610586033070
• UDI-Public: (01)10610586033070(17)290218(10)4463756
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

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: 21-3468-24
• Device Lot Number: 4463756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2024
• 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