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	Crack (1135)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A visual examination of the device noted no damage to the device.A leak test determined the device did not leak.The event is currently under investigation.This report includes relevant information known at this time. a follow up report will be submitted should additional relevant information become available.
Event or Problem Description
The international customer reported that turbo-ject® single lumen power-injectable picc (peripherally inserted central catheter) was cracked.The line had originally been implanted on (b)(6) 2017.On (b)(6) 2017, opacification of the product was noted, which was attributed by the customer to a lack of reflux.Diffusion was observed on the surface, which the customer postulated may have been due to a crack in the picc line.On (b)(6) 2017, thrombosis of the line was observed, which began at the initial portion of the left subclavian vein.The picc line was ultimately removed on (b)(6) 2017.The line was replaced with a mid line with an indication of passing a taxotere chemotherapy half-dose.The complaint product has been received for evaluation; however, as of the date of this report, the investigation is still ongoing.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawings, instructions for use (ifu), manufacturing instructions, quality control data, specifications, and visual inspection/functional testing of the device was conducted during the investigation.One device was returned for investigation.The length of the returned catheter is approximately 34.7 cm.A visual examination noted no damage to the catheter.There was lots of blood on the returned device.The device was flushed with water.A leak test determined the device did not leak.The failure could not be located.The customer¿s difficulty could not be recreated during the investigation.Additionally, physical investigation of the device noted no evidence of thrombosis on the product.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Based on the investigation evaluation, 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 review of the device history record showed no nonconforming events which could contribute to this failure mode.A review of the manufacturer's database identified one other complaint associated with lot 7883795 (same device, different failure mode [thrombosis]).However, this is being covered under this mfr.Report.The device is shipped with instructions for use, which states the proper warnings, precautions, and instructions for use.Device analysis found the product to meet and perform to required specifications, complaint unconfirmed.Based on the provided information a definitive root cause cannot be established or reported at this time.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 7188633
• Report Number: 1820334-2018-00003
• Device Sequence Number: 16161363
• Product Code: LJS
• UDI-Device Identifier: 00827002345195
• UDI-Public: (01)00827002345195(17)190503(10)7883795
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K132334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2018

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: UPICS-4.0-CT-NT-1111
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 01/12/2018
• Supplement Report FDA Received Date: 04/10/2018
• 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