MAUDE Adverse Event Report: CODMAN & SHURTLEFF INC. EVD/CSFF

Model Number 821730

Device Problems Improper Flow or Infusion (2954); Manufacturing, Packaging or Shipping Problem (2975); Protective Measures Problem (3015); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Patient information - no patient injury reported, device malfunction occurred.Relevant tests / laboratory data - not applicable as no patient injury occurred.Other relevant history, including preexisting medical conditions: not applicable as no patient injury occurred.If implanted date (mm/dd/yyyy) - not applicable as the medical device is not implantable.If explanted date (mm/dd/yyyy) - not applicable as the medical device is not implantable.Reprocessor name and address - not applicable as the medical device is not a single-use device that was reprocessed or reused on a patient.Concomitant medical products and therapy dates (excluding treatment of event) - not applicable to this type of device.For use by user facility / importer - not applicable as we are not a facility or importer of device.If nd, give protocol # - not applicable as the medical device is not ind.Adverse event terms - not applicable to medical devices.If remedial action initiated , check type - not applicable as no remedial action was initiated.If action reported to fda under 21 usc 360i (f), list correction / removal reporting number - not applicable as there was no action reported under 21usc 360i(f).

Event Description

Customer had another issue with a drainage bag failure.

Event Description

Customer had another issue with a drainage bag failure.

Manufacturer Narrative

Update 10th april 2020 (natus complaint ref.# (b)(4)).No parts returned to date for evaluation.Complaint form has been received.It was confirmed that there was a a delay in surgery but no patient injury.Investigation pending.

Manufacturer Narrative

Update 07th may 2020 (natus complaint reference #(b)(4) investigation results & findings product examination & functional testing product was not returned for evaluation therefore unable to evaluate product for functional testing.Without the suspect product being returned for evaluation , it is not possible to confirm or dispute the complaint at this time.Capa trending review there are no capa's related to this issue and this complaint does not identify a deficiency in the product design and therefore a capa is not required.Complaint trending review complaint history was reviewed for the previous two years and found 1 similar complaint, giving an incident rate of (b)(4).Per qms (b)(4) complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.No complaint trends have been identified.Risk management file review per dvd-drad00010 dfmea eds 3c and evd rev 17 - ref hazard id # 38, severity - 4, surgical delay- minor.Service record review service repair investigations will be conducted during the repair process and trend data will be reviewed per qms(b)(4).This issue will be continued to be monitored.This complaint will be included in trending data for further review and investigation if required.

Event Description

The customer had another issue with a drainage bag failure.

• Brand Name: EVD/CSFF
• Type of Device: EVD/CSFF
• Manufacturer (Section D): CODMAN & SHURTLEFF INC.; 325 paramount drive; raynham; massachusetts,
• MDR Report Key: 9821011
• MDR Text Key: 227200156
• Report Number: 2023988-2020-00006
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K061568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 821730
• Device Catalogue Number: 821730
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 02/11/2020; 02/11/2020
• Supplement Dates FDA Received: 04/10/2020; 06/08/2020
• Patient Sequence Number: 1