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	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported during insertion of a picc line the nurse tested the picc line and the plastic clamp which stops the picc from digging into the patient snapped in two.Reportedly the line was placed over the wire into the patient's arm for chemotherapy treatment and was easily removed and successfully replaced with another picc line packet as the wire was still in place.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the device history record, instructions for use (ifu), manufacturing instructions, quality control and visual inspection of the returned device was conducted during the investigation.One (1) single lumen peripherally inserted central catheter (picc) was returned for evaluation and visually examined.The returned device was 42.6 cm in length.The clamp was broken at the top of the backside of the clamp; the clamp had broken into two pieces.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.The device undergoes a 100% visual inspection of the clamp on the device.A review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, review of the returned device and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 5878240
• Report Number: 1820334-2016-00763
• Device Sequence Number: 1137273
• Product Code: FOZ
• UDI-Device Identifier: 00827002086647
• UDI-Public: (01)00827002086647(17)181220(10)6468970
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2016

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 Model Number: N/A
• Device Catalogue Number: PICS-501-MPIS-NT
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/16/2016
• Supplement Report FDA Received Date: 01/12/2017
• Patient Sequence Number: 1