MAUDE Adverse Event Report: COOK INC SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
510k #: k100974 (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
The international customer reported that the spectrum turbo-ject antibiotic power injectable picc (peripherally inserted central catheter) broke at the distal end of the device, just prior to the orange end.The product problem necessitated the rewiring of the line under local anesthesia in the interventional suite.The device had been placed on (b)(6) 2017, and the issue was discovered on (b)(6) 2017.Additional information was later received from the customer upon request.The break was described as a partial separation of the orange hub.The catheter was operational for 70 days prior to the discovery of the failure, and the issue was reportedly not with the hub itself, but rather the tubing that enters the hub portion of the device.The complaint product was primarily used for total parenteral nutrition infusion administered on a daily basis.The device has been returned; however, as of the date of this report, investigation and evaluation are in progress.
Event or Problem Description
The international customer reported that the spectrum turbo-ject antibiotic power injectable picc (peripherally inserted central catheter) broke at the distal end of the device, just prior to the orange end.The product problem necessitated the rewiring of the line under local anesthesia in the interventional suite.The device had been placed on (b)(6) 2017, and the issue was discovered on (b)(6) 2018.Additional information was later received from the customer upon request.The break was described as a partial separation of the orange hub.The catheter was operational for 70 days prior to the discovery of the failure, and the issue was reportedly not with the hub itself, but rather the tubing that enters the hub portion of the device.The complaint product was primarily used for total parenteral nutrition infusion administered on a daily basis.The device has been returned; however, as of the date of this report, investigation and evaluation are in progress.Further clarification was received regarding the meaning of "rewired".Per the customer, "the picc was broken at the junction of the orange hub and the clear tubing.We clean the extremity and the end of the catheter and feed a wire through the catheter to "maintain access" and remove the broken catheter and place a new catheter over the wire into the desired location".The customer also communicated that patient demographics and pre-existing conditions could not be detailed due to patient confidentiality.However, the manufacturer was made aware the patient is a child.
Additional Manufacturer Narrative
A review of the complaint history, device history record, documentation, drawings, instructions for use (ifu), quality control data and visual inspection of the device was conducted during the investigation.One used and damaged device was returned with a notable separation of the extension tubing from the orange hub.The product was air leak tested in a vessel of water.A stream of bubbles was observed from the region where the extension tube joins the proximal fitting of the device.Dimensional measurements of the referenced tubing were found to be within specification.The device history record was reviewed for both the finished device and the internal device component, and no non-conformances that were relevant to the failure were found.Additionally, a search of the manufacturer's complaint database revealed that this is the only complaint associated with lot 8147136 and 2 other complaints associated with the internal device component lot ic7426309.No evidence was found to support that the device was manufactured outside of cook medical specifications.The device was in place for 2 months before the failure was noted.Based on the provided information, inspection of returned product and the investigation, a definitive root cause cannot be established or reported at this time.However, measures have been previously initiated to address this issue.Appropriate personnel have been notified, and monitoring will continue to be performed 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: SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC
• Common Device Name: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7268618
• Report Number: 1820334-2018-00325
• Device Sequence Number: 19362216
• Product Code: FOZ
• UDI-Device Identifier: 00827002056763
• UDI-Public: (01)00827002056763(17)181117(10)8147136
• 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,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2018

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-3.0-CT-NT-ABRM-1110
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 03/27/2018
• 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