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

Model Number	21-2714-24
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other text: e4: initial reporter also sent report to fda is unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).No manufacturing or service issues were identified as causes of the customer's reported problem during the review of service and repair records.Ten (10) product samples were received for evaluation; the returned samples were decontaminated and without their original package inside a plastic bag.Visual and function testing was performed.Nine samples returned were from unused devices and no damage / broken can observed and one product sample was returned in another bag without the needle port.No actions taken since the failure is not associated with the manufacturing process.The reported issue was not duplicated.The root cause of the reported issue was unable to be determined.
Event or Problem Description
It was reported that the port needle broke off (snapped off) the handle part leaving the needle left in the patient.Additional information received on march 4, 2022 indicated the needle was able to be removed without harm or distress to the patient.

• Brand Name: DELTEC GRIPPER 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: jim vegel
• MDR Report Key: 16827107
• Report Number: 3012307300-2023-04690
• Device Sequence Number: 17857164
• Product Code: FPA
• UDI-Device Identifier: 10610586015786
• UDI-Public: 10610586015786
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K870866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/16/2025
• Device Model Number: 21-2714-24
• Device Catalogue Number: 21-2714-24
• Device Lot Number: 4037317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown