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

Catalog Number	C-RHCS-3.0
Medical Device Problem Codes	Fracture (1260); Leak/Splash (1354)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	03/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age: baby under 12 months.(b)(4).Pma/510(k) #: preamendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported during a repair of an lt cvc line, a cook tpn single lumen catheter repair set was found to leak near the hub.A pin prick hole was found after the repair line was glued in place when attempting to flush and check the line.To date, additional patient and event information has not been made available.
Event or Problem Description
It was reported during a repair of an lt cvc line, a cook tpn single lumen catheter repair set was found to leak near the hub.A pin prick hole was found after the repair line was glued in place when attempting to flush and check the line.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5-it was reported that there was one occurrence for this incidence.A line fracture resulted to the cvc line while attempting to repair.As a result, the patient received another line placement.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
It was reported during a repair of an lt cvc line, a cook tpn single lumen catheter repair set was found to leak near the hub.A pin prick hole was found after the repair line was glued in place when attempting to flush and check the line.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: it was reported that there was one occurrence for this incidence.A line fracture resulted to the cvc line while attempting to repair.As a result, the patient received another line placement.Investigation conclusion : the customer reported that the cook tpn single lumen catheter repair set had a pin hole in the repair near the hub.The complaint device was returned for investigation.A visual examination of the returned device was conducted and notes that the catheter had been jaggedly cut 2 mm from the repair kit that was applied to the device over the catheter separation.A review of the complaint history, the device history record and quality controls was conducted to aid in the investigation.Additionally during the investigation evaluation, a review of the current manufacturing and quality controls was conducted.This review surmised that the current process and quality inspection checks are in place to ensure the functionally and device integrity prior to shipment.No specific issue with this documentation that may have contributed to this failure mode was found, and the complaint devices were found to be manufactured within specification.A potential contributing factor that lead to this failure modes similar to this is due to operational context, however, the cause for this specific failure mode is not able to be established at this time.The complaint is confirmed based on the customer¿s testimony and the returned complaint device.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required at this time.However, this failure mode will continue to be trended.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Should additional information become available, the file will be updated accordingly.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 7489815
• Report Number: 1820334-2018-01331
• Device Sequence Number: 334079
• Product Code: DQY
• UDI-Device Identifier: 00827002021204
• UDI-Public: (01)00827002021204(17)190512(10)8513882
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: C-RHCS-3.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 05/11/2018; 05/11/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 07/02/2018; 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1