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	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	03/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dept: clinical procurement.(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported the peel away sheath for peripherally inserted central (picc) line insertion broke when attempting to peel it away.Consequently, the sheath could not be removed.This was rectified by having a second person scrub into the procedure and utilizing artery forceps to attach to the sheath and peel it away.No part of the device remained inside the patient.The patient did not require any additional procedures due to this occurrence.No adverse effects to the patient were reported due to this occurrence.
Additional Manufacturer Narrative
"adverse event and product problem" (b)(4).Investigation - evaluation: a review of device history record, manufacturing instructions, specifications, quality control and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device reported the sheath had separated from one of the two winged hubs of the introducer.Sheath material displays no discoloration or elongation at the point of separation which would be indicative of excessive pressure.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the risk assessment (ra) no further action is required.
Event or Problem Description
It was reported the peel away sheath for peripherally inserted central (picc) line insertion broke when attempting to peel it away.Consequently, the sheath could not be removed.This was rectified by having a second person scrub into the procedure and utilizing artery forceps to attach to the sheath and peel it away.No part of the device remained inside the patient.The patient did not require any additional procedures due to this occurrence.No adverse effects to the patient were reported due to this occurrence.

• 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: 5857677
• Report Number: 1820334-2016-00775
• Device Sequence Number: 370779
• Product Code: FOZ
• UDI-Device Identifier: 00827002083769
• UDI-Public: (01)00827002083769(17)180930(10)6250466
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PICS-301-MPIS
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2016
• Supplement Report FDA Received Date: 10/19/2016
• 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