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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Event is still under investigation at this time.
Event or Problem Description
The physician was placing the picc line and as the peel away sheath was being pulled to be peeled away, one of the handles on the sheath snapped off, leaving the sheath still attached to the picc line.The physician managed to retrieve the sheath from the picc line without the sheath handle and the line was successfully placed.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Product has been received and the investigation is ongoing.A follow up report will be sent upon completion of the investigation.
Event or Problem Description
The physician was placing the picc line and as the peel away sheath was being pulled to be peeled away, one of the handles on the sheath snapped off, leaving the sheath still attached to the picc line.The physician managed to retrieve the sheath from the picc line without the sheath handle and the line was successfully placed.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of complaint history, device history record, documentation, drawing, instructions for use (ifu), quality control data, and visual inspection of the returned device was conducted during the investigation.The supplied peel-away sheath introducer from the turbo-ject® double lumen bedside power-injectable picc having a product label lot number consisting of 6958927 was returned in an opened, used and damaged condition.The handles and the split peel away sheath were returned.The handle was broken in half.Visual examination of the handle revealed that there was incomplete fin fill where the hole punches are located.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, the root cause was determined to be manufacturing-related.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.

• Brand Name: TURBO-JECT® DOUBLE LUMEN BEDSIDE 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: 5833069
• Report Number: 1820334-2016-00716
• Device Sequence Number: 10829697
• Product Code: LJS
• UDI-Device Identifier: 00827002237155
• UDI-Public: (01)00827002237155(17)180509(10)6958927
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K072625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2017

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: UPICDS-4.0-CT-40NT-1110
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/04/2016
• Supplement Date Received by Manufacturer: Not provided; 07/25/2017
• Initial Report FDA Received Date: 07/29/2016
• Supplement Report FDA Received Date: 11/09/2016; 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1