MAUDE Adverse Event Report: COOK INC THREE-WAY PLASTIC ROTATING ADAPTER STOPCOCK; KGZ ACCESSORIES, CATHETER

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
During the process of giving cyto to the patient, it was noted that the product was leaking.Air is coming through the adapter when extraction of fluid is attempted; therefore, the extraction is impossible.Leaking has also occurred when fluid has been injected through the adapter, causing the fluid to end up on blanket or on the physician /nurse.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of complaint history, drawings, manufacturing instructions, quality control and a visual inspection and function test of the returned device was conducted during the investigation.The visual examination reported no physical defects were noted.Device was tested using water filled syringe.Both male ports of stopcock were tested in both open and closed positions and no leaks were noted.Device was also tested with 70 psi and again no leaks were noted.There is no evidence to suggest the product was not manufactured to current specifications.The manufacturing record for this lot was reviewed, and nothing of note was observed.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.It is unknown why the customer experienced difficulties.They could not be duplicated in the lab.A definitive root cause could not be determined.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.
Event or Problem Description
During the process of giving cyto to the patient, it was noted that the product was leaking.Air is coming through the adapter when extraction of fluid is attempted; therefore, the extraction is impossible.Leaking has also occured when fluid has been injected through the adapter, causing the fluid to end up on blanket or on the physician /nurse.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: THREE-WAY PLASTIC ROTATING ADAPTER STOPCOCK
• Common Device Name: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5615276
• Report Number: 1820334-2016-00267
• Device Sequence Number: 539424
• Product Code: KGZ
• UDI-Device Identifier: 00827002012035
• UDI-Public: (01)00827002012035(17)200624(10)NS5982288
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2016

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 Model Number: N/A
• Device Catalogue Number: 1PTWS-RA-R
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/06/2016
• Device Age: 10 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2016
• Supplement Report FDA Received Date: 09/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other