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

Catalog Number C-PICS-301J-RP-011195

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event - as reported, the device was found "split" a week after placement and removed on (b)(6) 2018.Placement is estimated to (b)(6) 2018.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported a single lumen peripherally inserted central venous catheter inserted in the jugular vein "split below the hub".A week after insertion, blood and other fluid was found on the patient's shirt.The patient was taken to the user facility were the device was examined and clamped.The line was later removed.Additional information with regards to the patient and event have been requested but not yet provided by the customer.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Additional information: it was reported to cook that the picc failed because the anesthetist "had not fully appreciated the importance of securing the hub of the picc under the dressing." additionally, the patient was on iv antibiotics when the picc broke.A replacement picc was placed a few days later in the same position when oral antibiotics were no longer working.Reportedly, a securacath was not used.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Device evaluation: the reported device was not returned to cook inc.For evaluation.Investigation: a document-based investigation reviewed the following: instructions for use, quality control specifications and manufacturing instructions.There is no evidence to suggest the finished product was not made to specifications.A review of the device history record of the finished product was unable to be performed as the lot number for the device was not available.A complaint history search was also unable to be performed due to the lack of a lot number.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The risk specification for this product includes the loss of use failure mode and identifies the risk controls that are in place to mitigate the risk of this type of failure.Conclusion: additional information was received from the customer and it was found that the user did not secure the hub under the dressing.Therefore, the definitive cause is likely "cause traced to user.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.Similar complaints will be continued to be monitored.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: SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7943510
• MDR Text Key: 123203685
• Report Number: 1820334-2018-03054
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K950118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-PICS-301J-RP-011195
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Patient Weight: 22