MAUDE Adverse Event Report: COOK INC SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	G08377
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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
It was reported that a nurse practitioner was inserting a silicone single lumen picc line into the left arm of a patient at the hospital and noticed that the hub of the picc line rotates "after adding the needleless cap".The complaint device failed upon placement near the external white hub.This device was placed in an active and mobile patient while saline was being flushed through the catheter.The malfunction prolonged the insertion process.No damage to the white hub was noted.No other adverse effects have been reported for this incident.
Event or Problem Description
No additional patient/event details have been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Correction:d4 (expiration date) and h4 were inadvertently left off of previous report.Investigation ¿ evaluation.A review of the documentation including the complaint history, device history record, instructions for use (ifu) and quality control, as well as a visual inspection of the returned device was conducted during the investigation.One single lumen peripherally inserted central venous catheter set was returned for investigation.The visual inspection of the complaint device noted the hub turns in a circular motion and the glue between the hub and snt has broken.Additionally, a document based investigation evaluation was performed.A review of the device master record found that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record found no nonconformances related to this incident.There are no other confirmed complaints reported for this lot.There is no evidence to suggest there is any nonconforming product in house or out in the field.Additionally, a review of the product labeling for the device was completed.The instructions for use was reviewed and no relevant instructions related to the reported failure mode were identified.Based on the information provided, inspection of the returned product, and the results of the investigation, a definitive cause was not established.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
• 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: 9266829
• Report Number: 1820334-2019-02751
• Device Sequence Number: 16659922
• Product Code: FOZ
• UDI-Device Identifier: 00827002083776
• UDI-Public: (01)00827002083776(17)220625(10)9836166
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K950118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/25/2022
• Device Model Number: G08377
• Device Catalogue Number: PICS-401-MPIS
• Device Lot Number: 9836166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CAP ¿ VADSITE FROM VYGON