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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Brand name: spectrum turbo-ject single 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
The customer reported that the spectrum turbo-ject single lumen minocycline/rifampin bedside power-injectable picc (peripherally inserted central catheter) was noted to be leaking from the hub area.The device was inserted for single indication of continuous milrinone infusion.The customer elaborated: "partial hub separation was noted and only handled for every 96 hours for tubing changes." ultimately, the picc line was removed and dreplaced with another picc line.The product is reportedly not available for return.
Additional Manufacturer Narrative
Investigation summary: a review of complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions and quality control data was performed.The complaint device was not returned therefore, device failure analysis and physical examination of the device used in this case could not be performed.The manufacturing documents in place at the time of manufacture were reviewed, and it was found that the device hub was visually inspected by quality control and no notable gaps in production or processing controls were noted.Sampled tensile testing is performed on the hub connection.The risk specification for this product includes the failure mode of hub separation and identifies that multiple risk controls are in place to mitigate the risk of this type of failure.The device history record for this lot number and component lot number were reviewed.No related non-conformances were identified.A search of our complaint records indicates that this is the only complaint on the lot number at the time of investigation.Per ifu, cook spectrum turbo-ject peripherally inserted central venous catheters with micro puncture peel-away introducers lists its intended use, instructions for use, precautions and warnings for our picc sets.The catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (crbsis).The cook spectrum turbo- ject picc is indicated for multiple injections of contrast media through a power injector.The maximum pressure limit setting for power injectors used with spectrum turbo-ject picc may not exceed 325 psi and the flow rate for 3 fr single lumen catheters may not exceed the maximum flow rate of 2ml/sec as shown table.Warning include statements instructing users, ¿do not power inject if maximum injection rate cannot be verified to meet limit¿¿, ¿the technician/health care professional must verify prior to use that the maximum pressure limit is set at or below 325 psi and that the maximum flow rate is at or below that which is listed on the catheter¿, and ¿failure to ensure patency of the catheter lumen prior to injection may result in catheter failure.¿ based on available information and device not being returned, a definitive root cause can not be determined at this time.The risk analysis for this failure mode was reviewed and it was determined that no additional risk mitigating activity is required at this time; however, measures have already been initiated to address picc extension tube splitting below the hub, and we cannot rule out that this event is related.We have notified the appropriate personnel to monitor for similar complaints.

• Brand Name: COOK SPECTRUM TURBO-JECT
• 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: 6857708
• Report Number: 1820334-2017-02628
• Device Sequence Number: 1111646
• Product Code: FOZ
• UDI-Device Identifier: 00827002237070
• UDI-Public: (01)00827002237070(17)180301(10)7143607
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2018

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-40NT-ABRM-1110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2017
• Supplement Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 09/12/2017
• Supplement Report FDA Received Date: 01/15/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention