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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.A follow-up report will be generated upon completion of the investigation.
Event or Problem Description
During an unknown procedure, the wire was contaminated by mistake and used.The wire was replaced with a new device to complete the procedure.Patient outcome is currently unknown.
Additional Manufacturer Narrative
Conclusion code: there is no indication of any adverse event or reportable malfunction as defined and required under 21 cfr part 803.No further investigation will be conducted.
Event or Problem Description
International customer reported that the guide wire was inadvertently contaminated while preparing for use.The contaminated device was removed from the sterile field and discarded.A replacement guide wire was obtained and the procedure completed without incident.There are no reports of any adverse event.There is no indication of a product malfunction.Accordingly, this report does not meet reporting criteria as defined under 21 cfr part 803.

• 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: 6294134
• Report Number: 1820334-2017-00157
• Device Sequence Number: 47668
• Product Code: LJS
• UDI-Device Identifier: 00827002037861
• UDI-Public: (01)00827002037861(17)180705(10)7094684
• Combination Product (Y/N): N
• PMA/510(K) Number: K111244
• 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
• Report Date (Section B): 04/18/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UPICS-5.0-CT-OTW-1110
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2017
• Supplement Report FDA Received Date: 04/18/2017
• 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