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

Model Number	G23712
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer (person): mobile: (b)(6).Occupation: pediatric surgeon.(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
It was reported that the line near the proximal hub of a turbo-ject single lumen bedside power-injectable picc fractured.The device was inserted in a pediatric patient on (b)(6) 2020.The patient was confined to the ward and in a wheelchair but was described to be "fit and well".The device was implanted for approximately five weeks before a fracture was noticed in the line around the proximal hub.The user facility's nursing staff believe that it is possible that the patient tampered with the device as an anti-tamper device was not placed over the catheter and the patient has tampered with previous devices before.As the patient requires tpn, the device was removed and replaced.No other adverse effects to the patient have been reported.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable or unchanged.Additional information: section c, d10.Investigation - evaluation.It was reported by (b)(6), a pediatric surgeon from (b)(6) general hospital, (b)(6), that a line that had been in place for 5 weeks has now fractured around the proximal hub of the catheter.The patient was a 13-year-old female with a non-specific mental health disorder diagnosis.The patient required the administration of total parenteral nutrition (tpn).The complaint device was reported to be a turbo-ject single lumen bedside power-injectable picc (rpn: upics-3.0-ct-40nt-1110, lot number 9718343) and was placed in the patient on (b)(6) 2020.It was reported that no ancillary devices were attached to the device.The fracture of the proximal hub was reported to have occurred on (b)(6) 2020.The device was removed and replaced.Regarding the patient¿s mobility, it was reported that the patient was confined to the hospital unit but was using a wheelchair.She was reported to be ¿fit and well.¿ despite the report that the patient has tampered with other devices in the past, an anti-tamper device was not used with the catheter.The staff reporting the device failure believes that the product failure was due to patient tampering.A review of the complaint history, device history record (dhr), instructions for use (ifu)and quality control, as well as a visual inspection of the returned device, was conducted during the investigation.One used turbo-ject® single lumen bedside power-injectable picc was returned to cook for evaluation.Upon visual inspection, it was noted that the clear extension tube is partially separated from the purple hub.Cook has concluded that the device was manufactured to specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhrs for the reported complaint device lot (9718343) and the related catheter component lot revealed no recorded non-conformances relevant to this failure mode.A database search found no other events associated with the reported device lot.Based on the information provided, cook has concluded that the available evidence indicates that product in house and in the field meets specification.Cook also reviewed product labeling.The turbo-ject® single lumen bedside power-injectable picc was supplied with the ifu, which includes the following: ¿-catheter maintenance: if catheter is not to be used immediately, its lumen should be maintained by continuous saline or heparinized saline drip or locked with a catheter locking solution.Note: if clc-2000, microclave or other needleless adapters approved for saline lock only are used, saline only catheter lock may be used¿.Catheter lock should be reestablished after every use or at least every 24 hours if unused.Before using catheter lumen already locked with heparin, lumen should be flushed with twice the indicated lumen volume using normal saline.Lumen should be flushed with normal saline between infusates.After use, lumen should again be flushed with twice the indicated lumen volume using normal saline before reestablishing catheter lock.¿ -intended use: the maximum pressure limit setting for power injectors used with the turbo-ject picc may not exceed 325psi and the flow rate may not exceed the maximum flow rate as indicated¿.Based on the information provided, inspection of the returned product, and the results of the investigation, a root cause for this event was unable to be established.The investigation was unable to rule out manufacturing, patient activity, catheter maintenance, or patient device tampering as a cause of this event.The patient was reported to have been confined to a wheelchair.If total assistance was needed for activities of daily living (adl), inadvertent tension may have placed on the line by the caregiver while performing adl¿s, during repositioning, or transitioning to the wheelchair from the bed.There is no information regarding the patient environment (e.G., bed rails/cribs, other medical devices) that may have caused the infusion lines attached to the device to become entangled and possibly result in unnecessary tension on the hub.It is also not unknown what accessories the device was attached to.If the device was attached to an infusion pump on a moving pole, it could have experienced strain/tension when the infusion pump pole or patient was moved.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Appropriate measures have been initiated to address this failure mode.A capa in in progress to further investigate this failure mode 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 additional patient/event information has been received since the previous medwatch report was sent.

• Brand Name: TURBO-JECT SINGLE 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: 10152811
• Report Number: 1820334-2020-01130
• Device Sequence Number: 19393267
• Product Code: LJS
• UDI-Device Identifier: 00827002237124
• UDI-Public: (01)00827002237124(17)210506(10)9718343
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2020

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: 05/06/2021
• Device Model Number: G23712
• Device Catalogue Number: UPICS-3.0-CT-40NT-1110
• Device Lot Number: 9718343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 08/11/2020
• 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: 13 YR