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	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/09/2017
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 peripherally inserted central catheter (picc) for an unspecified indication on (b)(6) 2017.The customer reported that the clinical unit noticed the picc line cracked and leaking on (b)(6) 2017.The handling conditions and circumstances leading to the event are not known.The catheter was explanted and replaced while the patient was under general anesthesia on (b)(6) 2017.No further event of patient details were provided.The device is available for evaluation, however it has not been received by the manufacturer as of the date of this event.
Additional Manufacturer Narrative
Investigation - evaluation: a review of functional test, complaint history, device history record, drawing, instructions for use, quality controls and visual inspection conducted during the investigation.The device was returned in a used and damaged condition.Upon examination a split was noted on the extension tube when the tubing was bent at the hub.The product was leak tested and a steady drip of water was noted under the hub.The outer diameter of the extension tube was measured and found to be in specification.There is no evidence to suggest the device was not manufactured to specification.The device history record was reviewed and noted one non-conformance which was not related to the reported failure.A complaint history search revealed this is the only complaint associated with this complaint.Based on the available information it is not clear if the leading cause to this event might be associated with an eventual intense mobilization of the patient (which could determine an eventual catheter breakage), an eventual medical procedure / user technique inaccuracy or an eventual malfunction of the device.Measures have been previously initiated to address this issue.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the health risk assessment no further action is required.

• 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: 6663798
• Report Number: 1820334-2017-01482
• Device Sequence Number: 816535
• Product Code: FOZ
• UDI-Device Identifier: 00827002056763
• UDI-Public: (01)00827002056763(17)180427(10)7142441
• 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): 10/30/2017

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: 05/31/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 10/30/2017
• 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