MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER MICRO BLUNT CANNULA, NON-CORING SA; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-3251-24
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when attempting to access the patient's port, it was noted to be very mobile and difficult to access.It was difficult to remove the safety needle and unable to obtain flashback or flush the line.A small adjustment was made and then the line was able to be flushed with 1-2 mls of saline.The port was removed.A blunt cannula was noted to be bent upwards approximately 45 degree from perpendicular form.There was a small amount of swelling and bleeding at the port site.The patient was sent to the hospital for further review and assessment.No medical or surgical intervention was reported.
Additional Manufacturer Narrative
No product sample was received; therefore, visual, and functional testing could not be performed.A device history record (dhr) review was performed, and no issues were noted during manufacture.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: DELTEC GRIPPER MICRO BLUNT CANNULA, NON-CORING SA
• Common Device Name: SET, ADMINISTRATION, 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: 15334517
• Report Number: 3012307300-2022-17202
• Device Sequence Number: 6927666
• Product Code: FPA
• UDI-Device Identifier: 10610586029745
• UDI-Public: 10610586029745
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K072059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2022

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: Health Professional
• Device Expiration Date: 10/15/2024
• Device Model Number: 21-3251-24
• Device Catalogue Number: 21-3251-24
• Device Lot Number: 3885530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2019
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown