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

Model Number 21-7391-24

Device Problems Material Fragmentation (1261); Mechanical Problem (1384)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Information was received indicating that a smiths medical cadd administration set was noted to have the line threaded through the side clamp and was unable to be rectified.The reporter indicated that the needle and introducer were inspected prior to insertion, needle was inserted into patient's lower back, then the needle was slowly withdrawn then a sudden loss of resistance was felt and only half of needle came out of the patient, other half broke off inside patients back on removal.The reporter indicated that neurologist came in and performed operation to remove remaining needle.No further adverse effects were reported.

Manufacturer Narrative

Other, other text: one sample was received in used condition.The product itself comes out from smh manufacturing without a needle, it was inspected just to confirm it does not have one.No manufacturing related solvent bonds were found inaccurately nor assemblies.A review of documentation and manufacturing processes found no defects in either.There was no fault found with the returned sample.

• Brand Name: CADD ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10114120
• MDR Text Key: 193615746
• Report Number: 3012307300-2020-05451
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027512
• UDI-Public: 10610586027512
• Combination Product (y/n): N
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7391-24
• Device Catalogue Number: 21-7391-24
• Device Lot Number: 3823334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2020
• Initial Date FDA Received: 06/03/2020
• Supplement Dates Manufacturer Received: 10/11/2020
• Supplement Dates FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention