MAUDE Adverse Event Report: COOK INC TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	G03785
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 the wire guide in a turbo-ject standard power injectable picc (peripherally inserted central catheter) was unable to be removed from the peel-away.The wire guide resembled a pigtail.To date, additional information regarding the device and patient has not been made available.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the dimensional verification, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the surface of the wire was in a damaged condition.The distal floppy tip appears to have been sheared off.The distal weld ball is missing.The coiling is missing from the distal tip.The sheared wire appears to have a pigtail shape.Also note, the proximal end of the wire appears to be in good condition.No damage was noted to the proximal end.No biological matter was visible on the damaged wire guide.No other damage was noted.Also of note, the dimensional length of the wire guide was noted.It was confirmed to be below tolerance however due to the damaged state it was received in, the wire guide was not out of specifications.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed 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, the examination of the returned product, 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: TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC
• Common Device Name: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7441509
• Report Number: 1820334-2018-01003
• Device Sequence Number: 1540151
• Product Code: LJS
• UDI-Device Identifier: 00827002037854
• UDI-Public: (01)00827002037854(17)200119(10)8520869
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2018

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: G03785
• Device Catalogue Number: UPICS-5.0-CT-NT-1110
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1