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

Catalog Number 21-2965-24

Device Problems Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; no information has been provided to date.Device not returned to manufacturer.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.

Event Description

It was reported that ¿a 48-hour diffuser was fitted to the patient the day before.Today, the patient returned with the needle seemingly at an angle and slightly protruding from the "pac", and white marks all around the "pac".It was stated that the patient's pajamas were soaked.The needle was removed, the diffuser (with 60 ml of product remaining) taken back down to the "upc".A similar situation (documented on cn-254069) occurred the previous day with another patient on the third day of him using his diffuser.He came normally for his session with traces of skin diffusion around the "pac" and the needle visibly out.His home nurse had noticed a "leak" around the needle the day before and had tried to replace it, without becoming alarmed or clamping the product.¿ there were no clinical consequences for the patients.The state of the event is resolved.The customer confirmed that the diffuser is not an icu medical product.The second event stated by the customer initially (cn-254069) "does not concern their facility".

• Brand Name: DELTEC GRIPPER PLUS NEEDLES
• Type of Device: 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: 18547547
• MDR Text Key: 333541129
• Report Number: 9617604-2024-00070
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027734
• UDI-Public: 10610586027734
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K021999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-2965-24
• Device Lot Number: 4400307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DIFFUSER LOT 1B3A133
• Patient Sex: Male