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

Model Number	G03788
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This mdr is being filed after the associated complaint was reviewed under remediation protocol_(b)(4), compliant/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
Two days after being placed the picc line was noted to be leaking so the patient's dressing was changed.Three days after the dressing was changed a crack was noticed in the white plastic area of the picc lines and the opening could not be used.Due to the cracks the picc line was replaced.According to the initial reporter, the patient did not experience any additional adverse effects due to this occurrence.

• 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: 6861367
• Report Number: 1820334-2017-02981
• Device Sequence Number: 873074
• Product Code: LJS
• UDI-Device Identifier: 00827002037885
• UDI-Public: (01)00827002037885(17)180115(10)6523750
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/13/2017

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: G03788
• Device Catalogue Number: UPICDS-5.0-CT-NT-1110
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 09/13/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention