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

Catalog Number	21-3367-24
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E3 - initial reporter occupation unknown.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 there was a dead space found at the connection between the transparent extension tube and the metal handle during the flushing of the port needle, which caused blood to remain and could not be rinsed clean.There was no patient involvement, and no patient harm reported.
Additional Manufacturer Narrative
D4 ¿ expiration date and primary udi number; corrected h6.Evaluation codes: updated.At the time of this investigation the physical device was not received for investigation.The customer provides two photos and one video.The photo shows a gripper plus sample, and the video shows the gripper sample in use.In the video it was possible to observe that fluid does not pass through the gripper, however, it is not clear why the fluid did not flow through the part, it is not clear why the fluid does not pass through the sample.The complaint was confirmed however the root cause could not be determined.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• Brand Name: DELTEC GRIPPER PLUS INJECTABLE
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20126005
• Report Number: 9617604-2024-00689
• Device Sequence Number: 7417261
• Product Code: FPA
• UDI-Device Identifier: 10610586033001
• UDI-Public: (01)10610586033001(17)281106(10)4442234
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072657
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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: 21-3367-24
• Device Lot Number: 4442234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2023
• 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
• Patient Sex: Unknown