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

Catalog Number	21-2770-24
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "it was impossible to purge the needle." the nurses changed the needle with one of the same lot number.There was no patient involvement.
Additional Manufacturer Narrative
H3: 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
One device was received for evaluation in used condition.Visual and functional testing was performed, and priming was unsuccessful.The occlusion area was severed at the tubing-needle junction point.A solvent membrane was observed within the needle lumen.The reported issue was confirmed.The probable cause is due to errant solvent applied at the tubing-needle bond.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• 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: 21942519
• Report Number: 3012307300-2025-05104
• Device Sequence Number: 12900097
• Product Code: FPA
• UDI-Device Identifier: 10610586025631
• UDI-Public: (01)10610586025631(17)291219(10)6070885
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K021999
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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: 21-2770-24
• Device Lot Number: 6070885
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• 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