MAUDE Adverse Event Report: COOK INC COOK TPN SINGLE LUMEN CATHETER REPAIR SET; DQY CATHETER, PERCUTANEOUS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The international customer reported that the part of the cook tpn single lumen catheter repair set "which is normally connected with the rest of the internal part, naked itself" [sic].The customer confirmed that, as a direct result of the product problem, the operator had to change out the device.Additionally, the pediatric patient experienced bleeding and required antibiotherapy.The conditions surrounding the usage and handling of the device are not known.The product is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.
Additional Manufacturer Narrative
Additional information: outcomes attributed to adverse event.Corrected data: the device has been returned for evaluation.Investigation ¿ evaluation: a review of the complaint history, instructions for use (ifu), device history record, specifications, and visual inspection of the returned device was conducted during the investigation.One device was returned.The length of the returned catheter is 9cm.A visual examination noted the seal between the tubing and the hub has pulled loose on the entire circumference.A thorough review of the device history record observed two (2) non-conformances for wrinkled seal associated with the complaint lot number; 7910528.These non-conformances were re-worked.A search of the manufacturer's database for similar complaints revealed this to be one (1) of six (6) records associated with the complaint lot number; 7910528.Based on the investigation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Measures have been initiated to correct this issue.Monitoring will continue to be performed for similar complaints.

• Brand Name: COOK TPN SINGLE LUMEN CATHETER REPAIR SET
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6897171
• Report Number: 1820334-2017-03252
• Device Sequence Number: 10904918
• Product Code: DQY
• UDI-Device Identifier: 00827002018686
• UDI-Public: (01)00827002018686(17)180509(10)7910528
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2017

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-RHCS-4.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/13/2017
• Supplement Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 09/27/2017
• Supplement Report FDA Received Date: 12/06/2017
• 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: Required Intervention