MAUDE Adverse Event Report: ST PAUL DELTEC; GRIPPERS

Model Number	22 GAUGE
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical implantable ports|deltec gripper plus needles malfunctioned.The report indicated during accessing port for chemo treatment the device flushed well prior to insertion.Upon insertion loud "click" heard and needle bent to approx.45 degrees.Device immediately removed and reported was in intact.Port re-accessed with another gripper and had no issue.No adverse patient events.
Additional Manufacturer Narrative
H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Units received: one unit was received for evaluation; the returned unit was received decontaminated and inside a plastic without its original package.Visual inspection results: it is observed the needle bent.The complaint is confirmed.Replication of the failure mode: a needle gripper was bent and tested using fixture t98-5494 to proof if the foam assembly could be performed with bent needle condition.Results: the bent samples could not fix in the t98-5494 cavities to perform the foam assembly.The most probable cause was traced to the user manipulation of the device, is that the product became damaged during use since the units cannot bet inserted in fixture t98-5177 if needle is bent.No corrective actions are required since it?s unlikely that needle was bent during the manufacturing process.

• Brand Name: DELTEC
• Common Device Name: GRIPPERS
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11845105
• Report Number: 3012307300-2021-04555
• Device Sequence Number: 17279567
• Product Code: FMI
• UDI-Device Identifier: 10610586025631
• UDI-Public: 10610586025631
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2022

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 Expiration Date: 11/23/2025
• Device Model Number: 22 GAUGE
• Device Catalogue Number: 21-2770-24
• Device Lot Number: 4076594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 08/22/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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