MAUDE Adverse Event Report: COOK INC ULTRATHANE SUPRAPUBIC CATHETER SET; KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES)

Model Number	N/A
Medical Device Problem Codes	Leak/Splash (1354); Torn Material (3024)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported by the user facility that a patient underwent a suprapubic tube insertion procedure at 12 noon.While in recovery at the hospital, the patient had to be taken back to the operating room due to the catheter leaking.The attending physician replaced the catheter with another ultrathane suprapubic catheter set.It was observed that the leakage was coming from the white part of the tube located at the end where the arm locks down.The customer stated, it was suggested that the cut occurred upon removal.There were no unintended sections of the device that remained inside of the patient¿s body, nor did the patient experience any adverse effects due to this occurrence.No further information was provided.
Additional Manufacturer Narrative
Investigation/evaluation: the investigation performed for this reported event included a review of complaint history, the device history record, documentation, drawings, and quality control data.A visual inspection and functional testing was also conducted during the investigation.The supplier also performed a device analysis.The device was returned in two pieces, the total measurement of the two pieces is 21.7cm in length.A visual examination noted the suture had been cut, but was still attached in the hub.A functional test was performed and a leak was confirmed in the hub of the device.The device was forwarded to the supplier for further analysis.The returned segment with the mac-loc assembly attached was leak tested with a syringe and water.The end was closed off and water pushed into the mac-loc assembly.The water leaked out from under the mac-loc lever.The lever was disengaged to check for the silicon insert.The insert was present, however was not properly placed inside the mac-loc.The mac-loc body was disassembled to confirm incorrect placement of the insert.The silicon insert was found to be pushed too far up inside the mac-loc body.A review of the device history records found there were no non-conformances noted during the manufacturing processes.A search of the complaints database revealed this to be the only complaint associated the device lot number 5106636.This is also the only complaint associated with component lot number f4872656.Based on the investigation evaluation, there is an indication that a manufacturing process-related failure mode contributed to this event.The quality engineering risk assessment has determined that no further action is warranted.Monitoring will continue to be performed for similar complaints.The appropriate personnel have been notified of this event.
Event or Problem Description
As reported to customer relations, "the patient had the catheter put in around 12 noon.While in recovery at the hospital, they had to bring her back to the o.R.Because the catheter was leaking.The catheter was replaced with a new g30401-j-uscs-120025." leaking part was the white part of the tube at the end where the arm locks down.It is believed that it was cut upon removal.

• Brand Name: ULTRATHANE SUPRAPUBIC CATHETER SET
• Common Device Name: KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES)
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6331382
• Report Number: 1820334-2017-00221
• Device Sequence Number: 13712421
• Product Code: KOB
• UDI-Device Identifier: 00827002304017
• UDI-Public: (01)00827002304017(17)170703(10)5106636
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K780765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-USCS-120025
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/23/2017
• Supplement Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 02/15/2017
• Supplement Report FDA Received Date: 01/22/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention