MAUDE Adverse Event Report: COOK INC TURBO-JECT POWER INJECTABLE; 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)
Date of Event	09/18/2017
Type of Reportable Event	Serious Injury
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
It was reported by the international customer that, at an undisclosed point in time following the opening and use of the product, "a rupture of the guide happened in the picc" [sic] (peripherally inserted central catheter).Additional information has been requested from the customer.The line was changed to resolve the product issue.The product is reportedly available for return; however, as of the date of this report, no product has yet been received for evaluation.
Additional Manufacturer Narrative
Investigation summary: a review of the dimensional verification, complaint history, device history record, documentation, instructions for use, manufacturer's investigation, specifications, drawing, quality control, and a visual inspection of the returned device were conducted during the investigation.One wire guide was returned in used condition, broken in the middle into two pieces (75 cm and 55 cm).It was not broken at a solder/weld joint.It was confirmed to be the 130cm wire guide and was found to be within specification.It should be noted that the wire guide broke around the 54.9cm marker zone.Additionally, a document based investigation evaluation was performed.There was no evidence to suggest the product was not made to specifications.A review of the device history record found no other non-conformance's associated with the complaint device lot number.It should be noted there were no other reported complaints for this lot number.The ifu states, ¿withdraw the needle, leaving wire guide in place.¿ 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.The quality engineering risk assessment for this failure mode was reviewed and it was determined that no additional risk mitigating activity is required at this time.The appropriate personnel will be notified and we will continue to monitor for similar complaints.

• Brand Name: TURBO-JECT POWER INJECTABLE
• 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: 6935279
• Report Number: 1820334-2017-03444
• Device Sequence Number: 566266
• Product Code: LJS
• UDI-Device Identifier: 00827002561946
• UDI-Public: (01)00827002561946(17)190510(10)7903192
• 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: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2017

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-5.0-CT-OTW-ST-1110
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/25/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 12/18/2017
• 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