MAUDE Adverse Event Report: ST PAUL EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7052-24

Device Problems Obstruction of Flow (2423); Priming Problem (4040)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Information was received indicating a cadd extension set line was occluded when priming on setup.It was reported the plastic was occluding the line.No patient involvement.

Manufacturer Narrative

(b)(6).

Event Description

Information was received indicating a cadd extension set line was occluded when priming on setup.It was reported the plastic was occluding the line.No patient involvement.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated h10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection: no discrepancies were detected in the sample, is visually acceptable.Functional testing on the sample received was performed using a syringe to look for unusual functions; liquid was introduced to the extension, however, can not flow to whole device an occlusion was detected in the outlet side filter, then a leaking start to flow from air vent filter; thus the failure mode reported is confirmed.Based on the tests results, it is concluded that the failure could be occurred in two ways: 1.When the excess of solvent is not cleaned before to assembly the tube with the component.2.When the tube is introduced two times in the solvent dispenser (procedure is not followed).The cause of the reported problem was traced to the manufacturing process.A dhr review was performed and no problems or issues were identified during this dhr review.

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: 3012307300-2022-03960.The report was submitted in error., corrected data: corrected information provided in h10.

• Brand Name: EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET
• 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; centrum 100; minneapolis, MN 55442
• MDR Report Key: 13585620
• MDR Text Key: 286009561
• Report Number: 3012307300-2022-03960
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586020346
• UDI-Public: 10610586020346
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K974013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7052-24
• Device Catalogue Number: 21-7052-24
• Device Lot Number: 4136387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1