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

Model Number	21-2961-24
Medical Device Problem Codes	Use of Device Problem (1670); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the use of the product, the skin at the puncture site became suppurated.Additionally the reporter stated "i recognize that it is a problem with the technique, but i would like you to analyze the product as well for good liquid flow.".
Additional Manufacturer Narrative
H10: no lot number was provided; therefore, device history record review could not be performed.A product sample was received for evaluation.Visual and functional testing was performed.Visual inspection found the sample was received in used condition and activated, and no issues was observed.Functional testing could not be performed since the sample was received in used condition and activated.Root cause analysis can be performed since the failure reported by the customer is not clear and failure could not duplicate in the manufacturing process since the product pass only for two kind of inspections ? visual inspection ? and ?occlusion test ?.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2022-14629.The report was submitted in error.

• Brand Name: DELTEC GRIPPER PLUS NEEDLE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: jim vegel ; 6000 nathan lane north; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 15163218
• Report Number: 3012307300-2022-14629
• Device Sequence Number: 14929086
• Product Code: FPA
• UDI-Device Identifier: 10610586027697
• UDI-Public: 10610586027697
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2023

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 Model Number: 21-2961-24
• Device Catalogue Number: 21-2961-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 12/22/2022; 06/20/2023
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 04/27/2023; 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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; Other
• Patient Sex: Unknown