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

Catalog Number	21-3465-24
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that after the end of treatment, when the needle was removed using the safety system, the needle came out of the safety system and stabbed the caregiver.There was a risk of injury to caregivers from a contaminated needle and exposure to bodily fluids.The outcome of the needle stick injury was not provided.
Additional Manufacturer Narrative
D9 - date returned to mfg: updated.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
D9: device received on 6/25/2025.H3: the returned sample consisted of nineteen (19) kits with their original unopened pouches inside from a plastic bag.The device history record of reported lot number 6061439 was reviewed, and it was confirmed that no non-conformities were reported during production.The quality inspection forms were reviewed, and it was observed that no defects were found, and the lot was released.Visual and functional tests were performed.The customer's stated problem was not confirmed.All samples functioned as designed and complied with expected safety mechanism performance.No failures were detected.There was no known cause of the reported issue, and no further action will be taken.

• Brand Name: DELTEC GRIPPER PLUS 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: 22061673
• Report Number: 3012307300-2025-05934
• Device Sequence Number: 20786602
• Product Code: FPA
• UDI-Device Identifier: 10610586033049
• UDI-Public: (01)10610586033049(17)291007(10)6061439
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2025

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: 21-3465-24
• Device Lot Number: 6061439
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 05/26/2025; 07/21/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/18/2025; 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown