MAUDE Adverse Event Report: COOK INC

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: turbo-ject over-the-wire single lumen peripherally inserted central venous catheter set.(b)(4).The event is currently under investigation.
Event or Problem Description
When the nurse went to administer medication for the male patient they found the infusate was leaking out at the catheter attachment junction with the lumen.The medication was omitted, device was removed and patient was discharged.The patient did not require any additional procedure.
Additional Manufacturer Narrative
Investigation - evaluation a review of the complaint history, device history record, trends, quality control and visual inspection of the returned device was conducted during the investigation.One turbo-ject over-the-wire single lumen peripherally inserted central venous catheter was returned measuring 31 cm in length.A visual examination noted the tubing has partially pulled away from the purple hub.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.Based on the information provided, examination of the returned device and the results of our investigation, a definitive root cause could not be determined.Measures have been initiated to address this issue.We will continue to monitor for similar complaints.

• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6244067
• Report Number: 1820334-2017-00029
• Device Sequence Number: 16400407
• Product Code: LJS
• UDI-Device Identifier: 00827002558847
• UDI-Public: (01)00827002558847(17)180906(10)7217618
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K111244
• 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): 06/15/2017

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UPICS-3.0-CT-OTW-1110
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2017
• Supplement Report FDA Received Date: 06/15/2017
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 47