MAUDE Adverse Event Report: COOK INC TURBO-JECT® DOUBLE 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 Codes	Hematoma (1884); No Code Available (3191)
Date of Event	01/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Visual inspection of the device confirmed the catheter is split 7 cm from the distal tip.The split was 2.5 cm in length.The investigation is still in progress.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
The international customer reported that, at an unspecified time following the use of the turbo-ject® double lumen power-injectable picc (peripherally inserted central catheter) for an unknown indication, a hematoma appeared at the patient's elbow.The catheter was split along a segment that spanned from 2 cm to 5 cm from the distal end of the device.A new device needed to be placed.The device has been returned for investigation; however, as of the date of this report, the device investigation is still pending.Additional information has been requested.
Additional Manufacturer Narrative
A review of the complaint history, device history record, documentation, quality control data and visual inspection of the returned device was conducted during the investigation.An investigation evaluation of the documentation was performed.There is no evidence to suggest the product was not made to specifications.There is no evidence to suggest that nonconforming product in house or in the field.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; 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.Review of device history record shows no nonconforming events associated with the complaint device lot number.At the time of the investigation, a review of the complaint records observed no other complaints associated with the complaint lot number 8297210.The complaint is confirmed.At this time a definitive cause cannot be determined for provided complaint.Per the quality engineering risk assessment no further action is required.

• Brand Name: TURBO-JECT® DOUBLE 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: 7283570
• Report Number: 1820334-2018-00365
• Device Sequence Number: 143598
• Product Code: LJS
• UDI-Device Identifier: 00827002239029
• UDI-Public: (01)00827002239029(17)191016(10)8297210
• 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,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2018

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: N/A
• Device Catalogue Number: UPICDS-5.0-CT-NT-1111
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 04/19/2018
• 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