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	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
International customer reported that a patient was scheduled to undergo placement of a turbo-ject standard power injectable picc line for an unspecified indication.The tip of the catheter sheath was observed to be damaged upon opening the package.The device was not used.A replacement catheter was obtained to complete the intended procedure.There are no adverse patient consequences related to this event.The device was received by the manufacturer for evaluation.
Additional Manufacturer Narrative
Investigation ¿ evaluation.A review of the complaint history, manufacturing instructions, quality control data and visual inspection was conducted during the investigation.The supplied plvw-5.0-18-7-denny-a peel away from the upicds-5.0-ct-nt-1110, turbo-ject standard power injectable picc line having a product label lot number consisting of 6537980 was returned in an opened, unused but damaged condition.A visual examination of the plvw-5.0-18-7-denny-a peel -away was confirmed to exhibit damage to the sheath at the distal tip.A review of the device history record (work order) was reviewed and confirmed that no nonconformance was recorded.To date, a further search of the manufacturer's records revealed this complaint to be the only reported complaint associated to the complaint lot number (6537980).The actual root cause is considered to be inconclusive.We will notify the appropriate personnel and continue to monitor for similar complaints.

• 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: 6683450
• Report Number: 1820334-2017-01646
• Device Sequence Number: 121787
• Product Code: LJS
• UDI-Device Identifier: 00827002037885
• UDI-Public: (01)00827002037885(17)180121(10)6537980
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K111244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2018

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: N/A
• Device Catalogue Number: UPICDS-5.0-CT-NT-1110
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 07/01/2017
• Supplement Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1