MAUDE Adverse Event Report: MEDIQUIP (MALAYSIA) DOVER; KIT, CATHETER, URINARY (EXLUDES HIV TESTING)

Model Number	1213-02
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 03/09/2017.An investigation is currently underway; upon completion the results will be forwarded.
Event or Problem Description
It was reported to covidien on (b)(6) 2017 that a customer had an issue with a urinary catheter.The customer states prior to use the balloon would not deflate.
Additional Manufacturer Narrative
An investigation of the reported condition was performed.The sample was tested for inflation and deflation test using water and no problem observed.The catheter balloon can be deflated completely and the volume recovery for the deflation complies with the standard.Time taken for the sample to deflate surpassed the standard requirement for deflation and passed the requirement.Thus the deflation of the balloon was within the standard.Therefore, the reported condition cannot be confirmed as the reported incident cannot be duplicated and product was found functional.Since the reported condition could not be duplicated and the sample was able to be inflated and deflated normally, an actual root cause for the reported condition cannot be specifically identified.The reported condition could not be confirmed, thus corrective action will be limited to the manufacturing awareness issue.No further corrective action is required at this time.This complaint will be recorded for tracking and trending purpose.This lot was manufactured as per the defined device master record.All acceptance criteria were met and this batch was released meeting all the acceptance criteria.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer states prior to use, the cuff would not deflate.
Additional Manufacturer Narrative
The returned sample was tested for inflation and deflation testing using water, and no problem was observed as it can be deflated completely, and the volume recovery for the deflation does comply with the standard.The amount of time taken for the sample to deflate was 156 seconds, surpassing the standard requirement for deflation within 900 seconds maximum period and passed the requirement as per stated in standard.Thus the deflation of balloon was within the standard.Therefore, the reported condition cannot be confirmed as the reported incident cannot be duplicated and product found functional satisfactorily.Since the reported condition could not be duplicated, and the sample able to be inflate and deflate normally, an actual root cause for the reported condition cannot be specifically identified.The reported condition could not be confirmed, thus corrective action will be limited to manufacturing awareness.No further corrective action is required at this time.This complaint will be recorded for tracking and trending purpose.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DOVER
• Common Device Name: KIT, CATHETER, URINARY (EXLUDES HIV TESTING)
• Manufacturer (Section D): MEDIQUIP (MALAYSIA); padang lati, mukim paya; kangar 01700 ; MY 01700
• MDR Report Key: 6394578
• Report Number: 9611712-2017-05002
• Device Sequence Number: 17956591
• Product Code: NWO
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2017

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: Health Professional
• Device Expiration Date: 11/15/2021
• Device Model Number: 1213-02
• Device Catalogue Number: 1213-02
• Device Lot Number: 6322B12QX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Initial Date Received by Manufacturer: 02/15/2017
• Supplement Date Received by Manufacturer: Not provided; 06/19/2017
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 06/19/2017; 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1