MAUDE Adverse Event Report: COOK INC Cook Spectrum Turbo-Ject; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Brand name: spectrum turbo-ject double lumen minocycline/rifampin bedside power-injectable picc.(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
Customer reported that a patient had a spectrum turbo-ject double lumen minocycline/rifampin bedside power-injectable peripherally inserted central catheter (picc) line placed on (b)(6) 2017 for an unspecified indication.The picc line reportedly broke on (b)(6) 2017.The break was observed on one of the extension lumens indicated to be the white lumen that is not power injectable.Customer states that the device broke right under the bottom of the plastic part with the information on it.The circumstances and handling conditions leading up to the event are not known.The device was completely explanted and replaced.No further patient information was provided.The device was received by the manufacturer for evaluation.
Additional Manufacturer Narrative
Investigation - evaluation: a review of dimensional verification, complaint history, device history record, drawing, ifu, and quality control data was conducted during the investigation., along with visual inspection of the actual device.A review of the device history record noted one non-conformance.This non-conformance was for a cogging and the device was scrapped.This non-conformance is not related to the device failure of this complaint.A review of complaint history noted that this is the only complaint associated with lot number 7521745.A level ii inspection was performed on incoming assemblies for imperfections and tensile strength.Parts were also level ii water tested for each extension.At final quality control test, it was confirmed that the correct stamped manifold assembly, extensions and proximal fittings/winged hubs and if specified, appropriate sheath material is securely molded.Also a final 100% dry leak test is performed to confirm all catheters are free of any leaks and/or communication between lumens and in manifold.No evidence was found to support that the device was manufacture outside cook medical specifications.Based on the provided information, inspection of returned product, and the investigation, a definitive root cause cannot be established or reported at this time.Per the quality engineering risk assessment no further action is required.We will notify the appropriate personnel and continue to monitor for similar complaints.

• Brand Name: Cook Spectrum Turbo-Ject
• 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: 6643291
• Report Number: 1820334-2017-00923
• Device Sequence Number: 19103309
• Product Code: LJS
• UDI-Device Identifier: 00827002345454
• UDI-Public: (01)00827002345454(17)180908(10)7521745
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UPICDS-4.0-CT-40NT-ABRM-1111
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/17/2017
• Supplement Date Received by Manufacturer: 09/09/2017
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 09/21/2017
• 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: 2 YR