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

Catalog Number UPICDS-5.0-CT-NT-1110

Device Problem Component(s), broken (1103)

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

Event Date 03/01/2015

Event Type  malfunction  

Event Description

After placing a picc line in a (b)(6) year old female patient's arm, the tubing of one of the two lines broke.The picc line had been placed on (b)(6) 2015 for the passage of the glucidion, amikacine and tienam.The patient has multiple disabilities with her arms and the picc line often retracted.The tubing was therefore, often bent.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

(b)(4).Product was returned in an opened and used condition.During investigation, a review of complaint history, quality control (qc) and instructions for use (ifu) was conducted.The visual inspection noted that the purple hub of the device was returned and had separated from the extension tube.The catheter shaft and extension tube were not returned with the hub.Per quality control spec, it is stated "confirm overall catheter assembly is clean and smooth." this product is shipped with an instructions for use which states warnings, precautions and instructions for use.The pt event info states: "the picc line had been placed on (b)(6), for the passage of the glucidion, amikacine and benam.The pt has multiple disabilities with her arms and the picc line often retracted.The tubing was therefore often bent." it is appropriate that the device was exposed to forces beyond its design causing this failure mode to occur.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera), the addition of this complaint does not change the conclusion that no further risk reduction is required.

Event Description

After placing a picc line in a (b)(6) female pt's arm, the tubing of one of the two lines broke.The picc line had been placed on (b)(6) 2015 for the passage of the glaucidium, amikacin and tienam.The pt has multiple disabilities with her arms and the picc line often retracted.The tubing was therefore, often bent.The pt did not require any add'l procedures due to this occurrence.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.

• Brand Name: TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC
• Type of Device: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool, mgr. ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4687633
• MDR Text Key: 22243176
• Report Number: 1820334-2015-00203
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 00827002037885
• UDI-Public: (01)00827002037885(17)161022(10)5382680
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K111244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,other,user faci
• Reporter Occupation: Unknown
• Type of Report: Initial,Followup
• Report Date: 03/09/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2016
• Device Catalogue Number: UPICDS-5.0-CT-NT-1110
• Device Lot Number: 5382680
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/19/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/01/2015
• Device Age: 5 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/10/2015
• Initial Date FDA Received: 04/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 35