MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. DELTEC SPLITSEPT Y-SITE GRIPPER HUBER NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-2947-24

Device Problem Disconnection (1171)

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

Event Date 12/07/2023

Event Type  malfunction  

Event Description

It was reported that after maintenance on the infusion port, the heparin cap was found disconnected when the sterile, implantable, intravenous drug delivery system was opened.The positive pressure connector was immediately connected in a sterile environment, and the infusion port was maintained again.There was patient involvement, but no harm adverse event was reported.

Manufacturer Narrative

H3: other: device has not been returned to date.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.

Manufacturer Narrative

H6 - evaluation codes: updated.Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: DELTEC SPLITSEPT Y-SITE GRIPPER HUBER NEEDLE
• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18588980
• MDR Text Key: 334838227
• Report Number: 9617604-2024-00083
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586016776
• UDI-Public: (01)10610586016776(17)271201(10)4345511
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K870866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

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
• Device Operator: Other
• Device Catalogue Number: 21-2947-24
• Device Lot Number: 4345511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/26/2024
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• 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