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	Crack (1135); 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 a crack in the hub area.The device was inserted for single indication of continuous treprostinil infusion.The customer elaborated: "partial hub separation was noted and the device likely only handled every 96 hours for tubing change." the device was reportedly inserted for 136 days prior to failure.Ultimately, the picc line was removed and replaced with another picc line.The product is reportedly not available for return.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use, manufacturing instructions, and quality control was completed during this investigation.The manufacturing documents at the time of manufacture were reviewed and it was found that the device aspect in question was visually inspected by quality control and no notable gaps in production or processing controls were noted.The risk specification for this product includes the failure modes ¿leakage / separation of hub¿ and ¿hub fracture¿ and identifies that multiple risk controls are in place to mitigate the risk of these types of failures.The device history record for lot number 6265569 and internal components ic6067130 were reviewed.No related non-conformances were identified.A search of our complaint records indicates that this is the only complaint on the involved lot numbers at the time of investigation.The product was not returned; therefore, the reported failure could not be duplicated.This is the first of two complaints for picc lines of different lot numbers used in the same patient in which the failure mode is described as leaking from a cracked hub.Based on the provided information, the root cause of this event is related to intra-venous tubing changing and repeated tightening of the device which may have contributed to the hub fracture and eventual separation or it may have been related to the forces that the hub experienced related to the patient's environment and activity level; however, we do not have enough evidence to identify a definitive root cause 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.We will continue 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: 6862012
• Report Number: 1820334-2017-02629
• Device Sequence Number: 16449467
• Product Code: FOZ
• UDI-Device Identifier: 00827002237070
• UDI-Public: (01)00827002237070(17)170819(10)6265569
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2017

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-40NT-ABRM-1110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 09/13/2017
• Supplement Report FDA Received Date: 11/02/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention