MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER PLUS POWER NEEDLES; PORT CATHETER, SUBCUTANEOUS, INTRAVASCULAR

Model Number	21-3468-24
Medical Device Problem Codes	Flushing Problem (1252); Priming Problem (4040)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that it was difficult to flush/prime with saline.No patient involvement reported.
Additional Manufacturer Narrative
The sample was received for evaluation.A device history record (dhr) review was performed which indicated all inspections were completed and no issues were noted during manufacture.Visual and functional testing were performed and the reported issue could not be confirmed.During visual inspection, no damage to the sample was observed.During functional testing, the reported issue could not be duplicated.Manufacturing controls are in place to help prevent occurrence of the reported issue.The root cause of the reported issue could not be determined.Operator of device is company representative.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: 617147.

• Brand Name: DELTEC GRIPPER PLUS POWER NEEDLES
• Common Device Name: PORT CATHETER, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15406447
• Report Number: 3012307300-2022-18785
• Device Sequence Number: 5640211
• Product Code: FPA
• UDI-Device Identifier: 10610586033070
• UDI-Public: 10610586033070
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2022

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: Other
• Device Model Number: 21-3468-24
• Device Catalogue Number: 21-3468-24
• Device Lot Number: 4042801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2022
• Initial Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 64 YR
• Patient Sex: Female