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

Model Number	N/A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2017
Type of Reportable Event	Malfunction
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, on (b)(6) 2017, a cook tpn single lumen catheter repair set was employed to repair a central venous catheter of unspecified manufacture.Approximately 48 hours later, on (b)(6) 2017, the repair kit began to peel off.The rupture was only of the outer membrane; the inner membrane remained intact, but it was necessary to repair it a second time.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The circumstances surrounding the handling and usage of the device are not fully known.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The product is reportedly available for evaluation, but as of the date of this report the device has not yet been returned.
Additional Manufacturer Narrative
Correction: event or problem.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, on (b)(6) 2017, a cook tpn single lumen catheter repair set was employed to repair a central venous catheter of unspecified manufacture.Approximately 48 hours later, on (b)(6), 2017, the repair kit began to peel off.The rupture was only of the outer membrane; the inner membrane remained intact, but it was necessary to repair it a second time.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The circumstances surrounding the handling and usage of the device are not fully known.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The product is reportedly available for evaluation, but as of the date of this report the device has not yet been returned.It was later reported in a response to a follow up request for additional information that the patient was 2 years old, and this device was used to repair the leaking complaint device which is the subject of mdr report # 1820334-2017-02634.
Additional Manufacturer Narrative
The device has been returned for evaluation.Investigation - evaluation: a review of the complaint history, device history record, instructions for use (ifu), specifications, and visual inspection of the returned device was conducted during the investigation.One device returned for investigation.A visual examination noted the seal between the tubing and the hub has pulled loose on the entire circumference.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.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, examination of the returned product, 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: 6854666
• Report Number: 1820334-2017-02633
• Device Sequence Number: 16366669
• Product Code: DQY
• UDI-Device Identifier: 00827002018686
• UDI-Public: (01)00827002018686(17)180509(10)8006708
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2017

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: C-RHCS-4.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 09/18/2017; 12/06/2017
• Initial Report FDA Received Date: 09/11/2017
• Supplement Report FDA Received Date: 10/09/2017; 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 YR