MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER PLUS NEEDLELESS Y SITE; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV

Catalog Number	21-3465-24
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Fragmentation (1261); Unexpected/Unintended Radiation Output (4028)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the iv tubing was stuck in the proximal port of the gripper plus.Port of the gripper plus broke off, leaving the line open/broken.The patient needed to be de-accessed and re-accessed.The proximal needleless port shattered.This caused debris and chemotherapy medication to go into the employee's eye.The employee was assessed in "employee health".No further follow up needed.
Additional Manufacturer Narrative
Other, other text: 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.
Additional Manufacturer Narrative
Other, other text: g1,2 email is: regulatory.Responses@icumed.Com.One (1) photo and one (1) video were provided by the customer which were used to conduct the device analysis since the physical unit, by the time this investigation was being documented, had not been received at the investigation site.Results: the photo shows a gripper plus safety huber needle inside a biohazard bag, the y-site is observed, no damage or dysfunctional conditions are observed.The video shows an unknown tubing set connected to the y-site of the gripper unit, in the video the user is observed attempting to remove the extension set from the gripper y-site, the user appears to be applying force to separate them but is unsuccessful.The reported failure mode, damage, was not confirmed.Functional testing: no product has been received to conduct a functional test.No other analysis was performed.Based on the photo and video no damage or fault can be identified.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 NEEDLELESS Y SITE
• Common Device Name: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17833184
• Report Number: 3012307300-2023-09337
• Device Sequence Number: 14316125
• Product Code: FPA
• UDI-Device Identifier: 10610586033049
• UDI-Public: 10610586033049
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 21-3465-24
• Device Lot Number: 4364655
• Was Device Available for Evaluation?: No
• 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: 09/06/2023
• Supplement Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown