MAUDE Adverse Event Report: COOK INC COOK SPECTRUM TURBO-JECT; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Brand name: spectrum turbo-ject double lumen minocycline/rifampin bedside power-injectable picc.(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the.
Event or Problem Description
The customer reported that the spectrum turbo-ject double lumen minocycline/rifampin bedside power-injectable picc (peripherally inserted central catheter) broke right below the orange hub of the device, at the connection between the orange hub and the clear line.The picc was placed on (b)(6) 2017 and the break was discovered by the patient contact on (b)(6) 2017.The break was described to be an incomplete break, as the orange hub itself was still intact.The patient contact covered the area with tegaderm, and was instructed to bring the patient in for examination.The patient was admitted for line replacement.The patient was receiving infusions of caspofungin and ambisome.A device was received for evaluation; however, as of the date of this report, the investigation is still pending.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, instructions for use (ifu), quality control, and visual inspection of the returned device was conducted during the investigation.One used device was returned.Biomatter was evident on the exterior of the device.A split in the clear extension tube, near the orange hub was noted.The failure was able to be duplicated.Room temperature water hand injected into the orange lumen produced a slow leak.The length, outer diameter, and inner diameter of the orange hub of the extension tubing were all within specification.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Review of the device history record of the finished product shows no nonconforming events.A review of the device history records for the internal components showed non-conformances; however, all non-conforming product was scrapped prior to completion of the final lot.There were no other reported complaints for this lot number.Based on the provided information, inspection of the returned product, and the results of our investigation; a definitive root cause could not be determined.However, measures have been initiated to address this failure mode.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: COOK SPECTRUM TURBO-JECT
• 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: 7126301
• Report Number: 1820334-2017-04373
• Device Sequence Number: 13755686
• Product Code: LJS
• UDI-Device Identifier: 00827002345454
• UDI-Public: (01)00827002345454(17)180831(10)7778600
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UPICDS-4.0-CT-40NT-ABRM-1111
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 YR