MAUDE Adverse Event Report: COOK INC TURBO-JECT POWER INJECTABLE; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/03/2017
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
International customer reported that a peripherally inserted central catheter (picc) line was implanted on (b)(6) 2017 for antibiotic therapy.The hub reportedly disconnected from the catheter after treatment on (b)(6) 2017.The conditions and handling circumstances at the time of the event are not known.The device was explanted; it is not known if a replacement device was exchanged.A section of the device did not remain inside the patient¿s body.No further patient or event information was provided.The device is reportedly available for evaluation; no device was received as of the date of this report.
Event or Problem Description
It was reported that a peripherally inserted central catheter (picc) line was implanted on 16 february 2017 for antibiotic therapy.The hub reportedly disconnected from the catheter after treatment on (b)(6) 2017.The conditions and handling circumstances at the time of the event are not known.The device was explanted and replaced with a new picc line.A section of the device did not remain inside the patient¿s body.No further patient or event information was provided.
Additional Manufacturer Narrative
(b)(4).A review of the complaint history, device history record, instructions for use (ifu), quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.Photographs provided by the customer show a catheter detachment.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.A review of the 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.Measures have been previously conducted to address this failure mode.We will continue to monitor for similar complaints.Per the health risk assessment no further action is required.

• Brand Name: TURBO-JECT POWER INJECTABLE
• 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: 6463209
• Report Number: 1820334-2017-00598
• Device Sequence Number: 580251
• Product Code: LJS
• UDI-Device Identifier: 00827002561991
• UDI-Public: (01)00827002561991(17)180707(10)7102234
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2017

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-4.0-CT-OTW-ST-1110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: 07/26/2017; 09/13/2017
• Initial Report FDA Received Date: 04/06/2017
• Supplement Report FDA Received Date: 08/01/2017; 09/27/2017
• 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
• Patient Age: 39 YR