MAUDE Adverse Event Report: CARDINAL HEALTH PRECISION 400 FLTY16FR WO PVPI; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	7016MF
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that a foley catheter was placed when a patient underwent surgery but the foley catheter could not be removed in the usual way because it was not able to be deflated completely so the doctor had to remove it in the end.There was no patient harm.It is not known if the customer tested the device during prep.
Additional Manufacturer Narrative
A lot number was not provided therefore the device history record could not be performed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One used 16fr catheter without a lot number was received for evaluation.A visual and functional inspection of the returned device was carried out however the reported condition could not be confirmed; the sample received meets the quality specifications and no abnormal conditions were observed during the testing and operation of the catheter.Since the reported issue was not confirmed, a root cause was unable to be determined and a corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: PRECISION 400 FLTY16FR WO PVPI
• Common Device Name: COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12987239
• Report Number: 9612030-2021-03119
• Device Sequence Number: 14879665
• Product Code: KNX
• UDI-Device Identifier: 10884521050617
• UDI-Public: 10884521050617
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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
• Device Model Number: 7016MF
• Device Catalogue Number: 7016MF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown