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

Model Number 21-2961-24

Device Problems Use of Device Problem (1670); Infusion or Flow Problem (2964)

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Event 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.".

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).

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
• Type of Device: 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
• MDR Text Key: 297222633
• Report Number: 3012307300-2022-14629
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027697
• UDI-Public: 10610586027697
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K021999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other