MAUDE Adverse Event Report: COOK INC LUER LOCK PLASTIC ADAPTER; KGZ ACCESSORIES, CATHETER

Model Number N/A

Device Problems Detachment Of Device Component (1104); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

Customer reported that a patient underwent a chest tube placement with a luer lock plastic adapter on an unspecified date.The luer lock plastic adapter reportedly separated allowing an air leak.It is not known if this event occurred during initial placement of a chest tube or at a time following placement.A description of the circumstances and patient activities surrounding the event was not provided.The customer reports that the event may have resulted in a "possible increased hospital stay;" no specific details were provided.Additional information was requested; no further information was received as of the date of this report.A followup report will be submitted upon receipt of any additional information.

Manufacturer Narrative

The customer previously reported that this event may have resulted in a possible increased hospital stay., but no specific details were provided.As of the date of this report, no further information was received.(b)(4).Investigation: a review of documentation, drawings, complaint history, device history record, and quality control data was conducted during the investigation.Complaint device evaluation was not performed since no product or imaging was returned to assist with this investigation.The manufacturing documents in place at the time of manufacture were reviewed and it was found that the device aspect in question was visually inspected by quality control.A review of the device history record for the lot in question confirmed no non-conformance's through manufacturing related to the failure mode.A search of our complaint records indicates that this is the only complaint on the lot numbers at the time of investigation.Similar failures of this type are documented in the product risk assessment.The document also assesses the severity associated with each failure mode, causes and effects of the failure, current risk controls in place, and the detection level of a particular failure.Current risk controls for the described failure mode include the adaptor components are designed with proper dimensions/tolerances and appropriate notes for applying adhesive, inspection of device functionality including a leak test, and final inspection where glue joint is twisted and verified to be adequate prior to shipping.Without visual, dimensional, or functional testing of the involved components a definitive root cause cannot be established or reported at this time a quality engineering risk assessment was performed to address this failure mode.No further action is required.We will notify the appropriate personnel and continue to monitor for similar complaints.

• Brand Name: LUER LOCK PLASTIC ADAPTER
• Type of Device: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6727972
• MDR Text Key: 80565990
• Report Number: 1820334-2017-01762
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002027275
• UDI-Public: (01)00827002027275(17)220428(10)7872030
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PMLLA-LHA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2017
• Initial Date FDA Received: 07/20/2017
• Supplement Dates Manufacturer Received: 11/08/2017
• Supplement Dates FDA Received: 11/28/2017
• Date Device Manufactured: 04/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1