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

Catalog Number	21-2965-24
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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".
Additional Manufacturer Narrative
D4: udi updated.H6: evaluation codes updated.Device evaluation: the reported complaint was unable to be confirmed as no sample was returned and no photos were provided.Testing was not conducted for the investigation.If the product is returned at a later date, the complaint will be reopened for further investigation.No non-conformances were found during the dhr review.

• 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: 18547547
• Report Number: 9617604-2024-00070
• Device Sequence Number: 9163580
• Product Code: FPA
• UDI-Device Identifier: 10610586027734
• UDI-Public: (01)10610586027734(17)280525(10)4400307
• 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,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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: 21-2965-24
• Device Lot Number: 4400307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DIFFUSER LOT 1B3A133
• Patient Sex: Male