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

Model Number 21-7052-24

Device Problem Partial Blockage (1065)

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

Event Date 02/21/2022

Event Type  malfunction  

Event Description

It was reported that smiths medical extension lines occluding.No injury.

Manufacturer Narrative

Other text: h6: event problem and evaluation codes: updated.H3: device evaluated by manufacturer: updated.H4: device manufacture date: updated.D10: device available for evaluation: updated.H10: device evaluation: the device was returned for investigation.Visual inspection and functional tests were performed.The customer reported problem was not related to any previous repair.Visual inspection found the device in good condition, all was intact, no physical damage present that could have cause the failure mode reported.The customer reported problem was not verified/duplicated.During the test, no occluded samples were found, and the water flowed without problem.The complaint was not confirmed.The root cause of the reported problem was unknown.No corrective actions were taken since the complaint was not confirmed.The lot was manufactured with 6,750 units, lot met the requirements to release the lot with no deviations identified during their manufactured., corrected data: correction: h4: mfg.Date.09-sep-2021.Correction: d4: expiration date 22-aug-2026.

Manufacturer Narrative

Event problem and evaluation codes: updated.H3: device evaluated by manufacturer: updated.H4: device manufacture date: updated.D10: device available for evaluation: updated.H10: device evaluation: the device was returned for investigation.Visual inspection and functional tests were performed.The customer reported problem was not related to any previous repair.Visual inspection found the device in good condition, all was intact, no physical damage present that could have cause the failure mode reported.The customer reported problem was not verified/duplicated.During the test, no occluded samples were found, and the water flowed without problem.The complaint was not confirmed.The root cause of the reported problem was unknown.No corrective actions were taken since the complaint was not confirmed.The lot was manufactured with 6,750 units, lot met the requirements to release the lot with no deviations identified during their manufactured., corrected data: correction: h4: mfg.Date.09-sep-2021 correction: d4: expiration date 22-aug-2026.

• Brand Name: CADD
• 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; glossop rd; minneapolis, MN 55442
• MDR Report Key: 13866411
• MDR Text Key: 287905743
• Report Number: 3012307300-2022-05110
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586020346
• UDI-Public: 10610586020346
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7052-24
• Device Catalogue Number: 21-7052-24
• Device Lot Number: 4183715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1