MAUDE Adverse Event Report: ST PAUL CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7092-24

Device Problems Backflow (1064); Fluid/Blood Leak (1250)

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

Event Date 08/21/2023

Event Type  malfunction  

Manufacturer Narrative

Other text: g3: france.D4: lot number, expiration date and h4 unknown as no lot number has been provided to date.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 information becomes available.

Event Description

It was reported that during an infusion of nacl and morphine a leak was observed at the valve between the y-connector and the rest of the tubing.Blood backflow into the central catheter was also observed.Per reporter the tubing was subsequently replaced, however, the leaking recurred a few hours later.No adverse patient effects were reported.

Manufacturer Narrative

Other, other text: additional information is provided for h.2.H.3., and h.6.Two samples were received for evaluation.Visual inspection revealed the samples were received in used conditions inside a plastic bag; no damage or defects were noted.Functional testing was performed, and the reported issue was able to be replicated.The root cause was determined to be due to manufacturing.No lot number was provided; therefore, a history record review could not be conducted.For all enquiries or follow-up questions related to the record, do not use (b)(6) located in sections g.1., please direct those to the following: (b)(6).

• Brand Name: CADD 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17821672
• MDR Text Key: 324330166
• Report Number: 3012307300-2023-09260
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586024177
• UDI-Public: 10610586024177
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K000942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 21-7092-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 03/20/2024
• 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