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

Catalog Number	21-3256-24
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle snapped during use.There was patient involvement.The new port needle was used to access the patient's implanted port.Upon disposing of the inducer in the sharps bin, the safety cover, which was supposed to cover the guide needle, popped back, exposing the needle and resulting in the needle stabbing the healthcare worker's finger.The details of the injury indicate a sharps injury sustained by the healthcare worker.No patient injury was reported.
Additional Manufacturer Narrative
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 g2 - report source: correction.H3 and h6.Codes: updated.Device evaluation: one device sample was received used in a plastic bag.It was observed that the needle was received in two separate parts.Per visual inspection the complaint can be confirmed however, since the sample was in used condition the failure mode reported cannot be attributed to the manufacturing process.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.The failure mode reported will continue to be monitored and if a trend is identified further investigation will be conducted.

• Brand Name: DELTEC GRIPPER MICRO 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: 21124083
• Report Number: 9617604-2025-00027
• Device Sequence Number: 8682744
• Product Code: FPA
• UDI-Device Identifier: 10610586029790
• UDI-Public: (01)10610586029790(17)290325(10)4469599
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/11/2025

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: 21-3256-24
• Device Lot Number: 4469599
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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