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

Model Number 21-2767-24

Device Problem Fluid/Blood Leak (1250)

Patient Problems Needle Stick/Puncture (2462); Localized Skin Lesion (4542); Reaction to Medicinal Component of Device (4574)

Event Date 08/01/2022

Event Type  Injury  

Manufacturer Narrative

No lot number provided.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.

Event Description

It was reported that a loss of drugs were detected in three (3) patients with standard home chemotherapy infusions.Patients presented a puncture area with a crystallized appearance around the device, and one of the patients presented a skin lesion at the reservoir site.Local and oral antibiotic prescriptions were required.Additional information was requested; however, no further information was received.

Manufacturer Narrative

H10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Two product samples were received for evaluation.Visual and functional testing was performed.Visual inspection found the safety mechanism activated; damage cannot be observed on the base and needle.Functional testing performed by introducing water with a syringe.Occlusion and leakage were not observed.Device passed all functional testing.No problem found.Root cause cannot be determined as the sample was successfully tested and no discrepancies were detected.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# 617147.

• Brand Name: DELTEC GRIPPER PLUS NEEDLES
• 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; minneapolis, MN 55442
• MDR Report Key: 15366390
• MDR Text Key: 299352564
• Report Number: 3012307300-2022-18043
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586025600
• UDI-Public: 10610586025600
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K021999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-2767-24
• Device Catalogue Number: 21-2767-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2023
• 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