MAUDE Adverse Event Report: COOK INC SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC; 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	05/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
International customer reported that a patient underwent placement of a spectrum turbo-ject antibiotic power injectable picc on (b)(6) 2017.The picc line broke on (b)(6) 2017.The circumstances and handling conditions leading up to the event are not known.The patient was admitted to the hospital and underwent catheter explant and replacement with a broviac catheter under general anesthesia.No further patient or event details were provided.The device is reportedly available for evaluation; however it has not been received by the manufacturer as of the date of this report.
Additional Manufacturer Narrative
The line experienced a partial separation at the connection of the tubing to the end of the hub.The line was being used for total parenteral nutrition (tpn).The device has been received for evaluation.Additional common name: foz ¿ catheter, intravascular, therapeutic, short-term less than 30 days.Additional product code: foz.510(k): k100974.Investigation - evaluation: a review of the dimensional verification, quality control data, complaint history, device history record, instructions for use (ifu), and visual inspection / functional testing of the returned device was conducted during the investigation.The device was returned in used condition.The extension tube was noted to be split right underneath the distal part of the orange hub.A leak test showed leakage at the split.The outer diameter of the extension tube was within specification.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to the reported failure mode.There was one other reported complaint for this failure mode on this lot number.Based on the provided information, inspection of returned product, and results of the investigation; a definitive root cause cannot be determined.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.

• Brand Name: SPECTRUM TURBO-JECT ANTIBIOTIC 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: 6683458
• Report Number: 1820334-2017-01613
• Device Sequence Number: 16175338
• Product Code: LJS
• UDI-Device Identifier: 00827002056763
• UDI-Public: (01)00827002056763(17)180928(10)7713230
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2017

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: UPICS-3.0-CT-NT-ABRM-1110
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/12/2017
• Supplement Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 07/01/2017
• Supplement Report FDA Received Date: 10/25/2017
• 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