MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE SET; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number	N/A
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
The international customer reported that as metal particle was observed to be inside the packaging of the ultrathane mac-loc locking loop multipurpose drainage set.This was discovered prior to use during a stock inspection.Accordingly, the product problem did not result in any patient adverse events.The product has been returned to the manufacturer; however, as of the date of this report, the investigation is still in progress.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, manufacturing instructions, quality control, specifications, and visual inspection of the device was conducted during the investigation.The device was returned.Visual inspection identified foreign matter within the properly sealed packaging.Device failure analysis found no damage to the seals or packaging and therefore it has been concluded that the root cause is manufacturing related.A review of the main work order ((b)(4)) shows two unrelated non-conformances.It should be noted there were no other reported complaints for this lot number.We have notified the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Additional Manufacturer Narrative
Additional information: date of event.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE SET
• Common Device Name: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7301780
• Report Number: 1820334-2018-00424
• Device Sequence Number: 1994077
• Product Code: GBO
• UDI-Device Identifier: 00827002100497
• UDI-Public: (01)00827002100497(17)201206(10)NS8325507
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2018

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: No Information
• Device Model Number: N/A
• Device Catalogue Number: CLM-8.5-RH-NPAS-NT
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 03/07/2018; 04/04/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 04/03/2018; 05/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1