MAUDE Adverse Event Report: COOK INC TURBO-JECT SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
The 3 fr picc line was placed in the patient on (b)(6) 2016 for antibiotic treatment.On (b)(6) 2016, the line was noted to have cracked (1820334-2016-00661).The reporter states the same issue occurred with a 4 and 5fr double lumen picc's.This is the patient's second malfunction, the first was in (b)(6) 2016, according to the patient's mother.The patient only had it in for a week for antibiotics at that time.Patient returned on (b)(6) 2016 to have the device replaced.
Additional Manufacturer Narrative
Initial reporter: dept: interventional radiology.(b)(4).Investigation - evaluation: a review of the complaint history, device history record and specifications was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was 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.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.Per the health risk assessment no further action is required.
Event or Problem Description
The 3 fr picc line was placed in the patient on (b)(6) 2016 for antibiotic treatment.On (b)(6) 2016, the line was noted to have cracked (1820334-2016-00661).The reporter states the same issue occurred with a 4 and 5fr double lumen picc's.This is the patient's second malfunction, the first was in (b)(6) 2016, according to the patient's mother.The patient only had it in for a week for antibiotics at that time.(1820334-2016-00689).Patient returned on (b)(6) 2016 to have the device replaced.

• Brand Name: TURBO-JECT SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
• Common Device Name: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5808366
• Report Number: 1820334-2016-00689
• Device Sequence Number: 605390
• Product Code: LJS
• UDI-Device Identifier: 00827002558830
• UDI-Public: (01)00827002558830(17)171019(10)6292650
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K111244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2016

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-NT-1110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2016
• Supplement Report FDA Received Date: 10/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1