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

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
The patient had a picc line placed for total parenteral nutrition.On two separate occasions, a crack in the lumen was noted just beneath the hub in a short space of time after their insertion (mdr# 1820334-2016-00606).The picc lines were removed and a new line was inserted.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: during the course of the investigation, a review of the complaint history, device history record, and specifications of the product was conducted.A review of the production documentation was conducted.Specific issues with the current manufacturing controls that may have contributed to this incident were not observed.There is no evidence to suggest that the device was not made to specification.The complaint device was not returned.Therefore, a definitive root cause could not be determined.We will continue to monitor for similar complaints.
Event or Problem Description
The patient had a picc line placed for total parenteral nutrition.On two separate occasions, a crack in the lumen was noted just beneath the hub in a short space of time after their insertion (mdr# 1820334-2016-00605 and 1820334-2016-00606).The picc lines were removed and a new line was inserted.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.

• 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: 5790202
• Report Number: 1820334-2016-00605
• Device Sequence Number: 1456816
• Product Code: LJS
• UDI-Device Identifier: 00827002037885
• UDI-Public: (01)00827002037885(17)180407(10)6874460
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2016

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: UPICDS-5.0-CT-NT-1110
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/13/2016
• Supplement Report FDA Received Date: 09/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1