MAUDE Adverse Event Report: COVIDIEN SAF VAC 6 FR 2 LF GL CUP KIT; CATHETER AND TIP, SUCTION

Model Number	36626
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.  if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported they experienced a critical product issue where the graduated numbers were printed in reverse.This issue was discovered prior to use in the newborn intensive care unit.
Additional Manufacturer Narrative
The device history record (dhr) file was reviewed indicating that product was released meeting all quality standard requirements.There were no samples submitted with this complaint.The complaint will be reopened if a sample is received.The reported condition was unable to be confirmed for this complaint.A formal investigation was open to determine the root cause and implement the appropriate corrective and preventative action (capa) because of a previously confirmed complaint from the same customer, where the sample was returned.The capa is currently in the open investigation phase.The production personnel were notified about the condition as well.A quality alert was generated to document the printed in reverse issue and incorrect assembly failure mode.The corrective actions will be addressed during the capa investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: SAF VAC 6 FR 2 LF GL CUP KIT
• Common Device Name: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9239162
• Report Number: 9612030-2019-02330
• Device Sequence Number: 127447
• Product Code: JOL
• UDI-Device Identifier: 10884527002412
• UDI-Public: 10884527002412
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2019

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
• Operator of Device: No Information
• Device Model Number: 36626
• Device Catalogue Number: 36626
• Device Lot Number: 1910621864
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 12/31/2019
• Patient Sequence Number: 1