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

Model Number	N/A
Medical Device Problem Code	Split (2537)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/04/2017
Type of Reportable Event	Malfunction
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 was undergoing placement of a turbo-ject® single lumen power-injectable picc for an unspecified indication.The customer states that the "catheter dissected between 13 and 15 cm and cut to the 17 cm.Problem seen with the removal of the catheter." there are no reported averse patient consequences.The customer advised that no section of the device did not remain inside the patient¿s body and the patient did not require any additional procedures due to this occurrence.The device is reportedly available for evaluation.
Additional Manufacturer Narrative
Corrected data: pma/510k.Investigation - evaluation: a review of device history record, quality control, specifications, instructions for use (ifu), complaint history, drawings, documentation, and visual inspections was conducted during on the returned product during the investigation.One device was returned for investigation.A visual examination of the returned device noted the tubing burst and split at 29cm from the distal tip.The split length measures 1.8cm.The tubing was found to be stretched at the 32cm mark for a length of approximately 2cm.Dried blood was found packed inside the tubing at the location of the split.The turbo-ject® single lumen power-injectable picc is shipped with instructions for use: (ifu), which clearly states the proper warnings, precautions, and instructions for use.Specifically; ¿extreme caution must be used in placement and monitoring.Silicone catheters are not designed for power injection.Catheter rupture may occur.Use of a 10 ml syringe or larger will reduce the risk of catheter rupture.If lumen flow is impeded, do not force injection or withdrawal of fluids.Catheter size should be as small as the use will allow¿.There is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.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 did not observe any non-conformances that may have contributed to this incident associated with the complaint lot number.A complaint history search revealed this complaint to be the only record associated with the complaint lot number.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: TURBO-JECT® SINGLE LUMEN 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: 6731748
• Report Number: 1820334-2017-01787
• Device Sequence Number: 19037953
• Product Code: LJS
• UDI-Device Identifier: 00827002238978
• UDI-Public: (01)00827002238978(17)190215(10)7679683
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K132885
• 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): 10/17/2017

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: UPICS-5.0-CT-NT-1111
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/06/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1