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

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

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 the luer lock separated from the drainage adaptor during placement of a chest tube.The handling circumstances and conditions surrounding the event are not known.The event caused an air leak which resulted in an extended hospital stay.There was no direct patient harm or adverse patient consequence.No further information was provided.The actual device is not available for evaluation.

Manufacturer Narrative

Investigation - evaluation.A review of complaint history, device history record, documentation, drawing, and quality control was completed during this investigation.The product will not be returned for the investigation.If the device becomes available complaint will be reopened and investigation will be performed at that time.A complaint history search revealed this complaint to be the only reported complaint associated to the complaint lot number 7382108.It is feasible to suggest the device encountered forces beyond its intended design, which led to the noted failure.It is also possible that there was insufficient adhesive added to the threads of the flare tube, causing the to attached pieces to come apart upon manipulation.However, without visual, dimensional, or functional testing of the involved components, we are unable to determine with certainty what led to this failure mode.The root cause of the failure is determined to be inconclusive.The device history record for lot 7382108 was reviewed and noted one (1) non-conformance which was potentially related to this failure mode.We have notified the appropriate personnel and will continue to monitor for similar complaints.According to a quality engineering risk analysis no further action is required at this time.

• 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: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6410571
• MDR Text Key: 70117806
• Report Number: 1820334-2017-00356
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002027275
• UDI-Public: (01)00827002027275(17)211024(10)7382108
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/31/2017

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?: No
• 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?: No
• Initial Date Manufacturer Received: 02/14/2017
• Initial Date FDA Received: 03/16/2017
• Supplement Dates Manufacturer Received: 08/16/2017
• Supplement Dates FDA Received: 08/31/2017
• Date Device Manufactured: 10/24/2016
• 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
• Patient Outcome(s): Hospitalization