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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/31/2017
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 patient had a turbo-ject standard power injectable picc line placed on an unspecified date for an unspecified indication.The customer reports that leakage was noted as a result of a crack in the picc line.The handling conditions and circumstances leading up to the event are not known.The device was completely explanted and replaced with a new device.There are no reported adverse patient consequences related to this event.The device is reportedly available for evaluation, however it has not been received by the manufacturer as of the date of this event.
Additional Manufacturer Narrative
A review of device history record, documentation, specification, and quality control data was conducted during the investigation.One opened complaint device was returned for investigation.A visual examination noted the clear tubing is partially separated from the purple hub.The patient did not experience any ¿adverse effects;¿ however, an additional procedure(s) was required for another picc line placement, due to this occurrence.The turbo-ject standard power injectable picc line picc is shipped with instructions for use which clearly states the proper warnings, precautions, and instructions for use.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.A thorough review of the device history record revealed no non-conformances that may have contributed to this incident.A complaint history search for similar complaints revealed this complaint to be the only record associated with complaint lot number a definitive root cause could not be determined; however, based on the provided information and evaluation of the returned device, the actual root cause is ¿inconclusive.¿ we will notify the appropriate personnel and continue to monitor for similar complaints.Measures have been previously initiated to address this issue.Per the quality engineering risk assessment no further action is required.

• Brand Name: TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC
• 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: 6667000
• Report Number: 1820334-2017-01476
• Device Sequence Number: 16154749
• Product Code: LJS
• UDI-Device Identifier: 00827002037779
• UDI-Public: (01)00827002037779(17)180513(10)6968801
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2017

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: UPICS-4.0-CT-NT-1110
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/31/2017
• Supplement Date Received by Manufacturer: 08/14/2017
• Initial Report FDA Received Date: 06/26/2017
• Supplement Report FDA Received Date: 08/30/2017
• 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