MAUDE Adverse Event Report: COOK INC TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	07/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported during antibiotic therapy that the purple hub on the picc line cracked.Also, the needleless connector was hard to remove and replace.The picc line was removed after 35 days insitu.It was not replaced.The patient was placed on oral antibiotics.
Additional Manufacturer Narrative
(b)(4).No known impact or consequence to patient (the catheter was removed and the patient placed on oral antibiotics).Investigation - evaluation a review of complaint history, device history record, instructions for use (ifu), specifications and visual inspection of the returned device was conducted during the investigation.The turbo-ject® double lumen over-the-wire power-injectable picc was returned for evaluation.The device was returned with a connector that was tacky and the hub cracked axially.40.1 cm of the catheter was returned.A document based investigation evaluation was also 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.There were two additional reported complaints for this lot number.Based on the information provided and results of the investigation, a definitive root cause could not be determined.Measures have been previously initiated to address this issue.Monitoring for similar complaints will continue.

• Brand Name: TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE 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: 5858039
• Report Number: 1820334-2016-00752
• Device Sequence Number: 269315
• Product Code: LJS
• UDI-Device Identifier: 00827002345164
• UDI-Public: (01)00827002345164(17)170714(10)5984658
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K132334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,user facilit
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2017

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: No Information
• Device Model Number: N/A
• Device Catalogue Number: UPICDS-4.0-CT-OTW-ST-1111
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/13/2016
• Supplement Date Received by Manufacturer: 08/28/2017
• Initial Report FDA Received Date: 08/09/2016
• Supplement Report FDA Received Date: 09/01/2017
• Patient Sequence Number: 1