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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
On (b)(6) 2019, several months after insertion of the picc, a leak was noticed at the junction of the clear lumen and purple luer hub.As reported the young lady is very active (dance lessons, etc) but mother is very careful to use self adhesive bandage over the site and total parenteral nutrition (tpn) is carried in a backpack during the day.On (b)(6) 2019, wire exchange was performed with difficulty, but successfully.There were no associated adverse events, although the wire exchange was challenging due to the patient's anxiety.The customer reports the product is available for return, but it won¿t be available until the end of may (as the clinician is away).
Additional Manufacturer Narrative
Investigation - evaluation: a review of documentation including the complaint history, device history record, instructions for use (ifu), quality control and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, a physical examination could not be completed.However, a document-based investigation evaluation was performed.It was concluded that the device aspect in question was visually and functionally inspected by quality control and no related gaps in production or processing controls were noted.The risk specification for this product includes the loss of use failure mode and identifies the risk controls that are in place to mitigate the risk of this type of failure.A review of the device history record for lot 9201791 revealed no nonconformances that could have contributed to this failure mode.It should be noted that there were no other complaints reported for this lot number.There is no evidence to suggest that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: intended use: the maximum pressure limit setting for power injectors used with the turbo-ject picc may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated, as shown on the following table.Warnings: the safe and effective use of turbo-ject picc lines with power injector pressures set above 325 psi has not been established.Do not power inject if maximum injection rate cannot be verified to meet limit printed on catheter hub or extension tube.To safely use turbo-ject picc lines with a power injector, the technician/health care professional must verify prior to use that the maximum pressure limit is set at or below that which is listed on the catheter.Dynamic and static pressure test results are shown in the following table.Precautions: if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify attending physician immediately.How supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cook place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided, no returned product and the results of our investigation, a definitive root cause could not be established.Appropriate measures have been taken to address this failure mode.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
Additional information: d10.Concomitant medical product received on: 13aug2019.Update: investigation ¿ evaluation.A visual inspection of the returned device was conducted.One turbo-ject standard power injectable picc line picc was returned for evaluation in two segments.Upon visual inspection, it was confirmed that the clear tubing has partially separated from the purple hub.Based on the examination of the returned product, a definitive root cause could not be established.This conclusion remains unchanged from the previous investigation.Appropriate measures have been taken to address this failure mode.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No new event description information to report at this time.

• 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: 8640468
• Report Number: 1820334-2019-01306
• Device Sequence Number: 1680927
• Product Code: LJS
• UDI-Device Identifier: 00827002037779
• UDI-Public: (01)00827002037779(17)201001(10)9201791
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K111244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: N/A
• Device Catalogue Number: UPICS-4.0-CT-NT-1110
• Device Lot Number: 9201791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 07/22/2019; 08/15/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 08/12/2019; 08/29/2019
• 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
• Patient Age: 9 YR