MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER PLUS NEEDLES; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-2767-24
Medical Device Problem Codes	Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle was "too high above the level of the children's skin after being punctured, which caused accidental hits and the catheters became loose".There was extravasation of serum therapy in several patients.The needle bent inside the catheter, causing harm to patients.There was patient involved, but it is unknown the exact quantity and reported harm.It was unknown if there was any medical intervention or treatment.
Additional Manufacturer Narrative
Other text: d3, g1,2 email is: (b)(6).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
Evaluation codes: email is: (b)(6).Three (3) photos were provided by the customer which were used to conduct the device analysis since the physical unit, by the time this investigation is being documented, has not been received.Results: photo one shows a top view of the needle base where the needle is observed to be bent towards the front of the base, the unit is observed to be used and blood traces are in the tubing.Photo two shows a bottom view of the base of the needle where the needle is observed to be bent at the edge of the base toward the front end.Photo three shows a side view of the base where the needle is observed to be bent towards the front and the foam is observed to be compressed due to the bent needle.The complaint was confirmed.No product has been received to conduct a functional test.The root cause is unknown.Without the return of the involved sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.If the device arrives, the manufacturer will reopen this complaint for further device analysis and investigation.

• Brand Name: DELTEC GRIPPER PLUS NEEDLES
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert
• MDR Report Key: 18240592
• Report Number: 3012307300-2023-10883
• Device Sequence Number: 11573320
• Product Code: FPA
• UDI-Device Identifier: 10610586025600
• UDI-Public: 10610586025600
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K021999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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: 21-2767-24
• Device Lot Number: 4235303
• 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: 04/06/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• 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
• Patient Sex: Unknown