MAUDE Adverse Event Report: COOK INC DRAINAGE BAG CONNECTOR CONNECTING TUBE

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	01/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common device name: connector, catheter; procode: gcd; (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 customer reported that, during an inspection of an unopened drainage bag connector connecting tube, a strain of hair was seen in the package.The issue was discovered prior to use on a patient; accordingly, no patient adverse events occurred as a result of the issue.The device is reportedly available for return; however as of the date of this report, no device has yet been received for evaluation.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, specifications, quality control data, and visual inspection was conducted during the investigation.The complaint device was received open and taped closed.There was a visible strand of hair/string-like foreign matter within the pouch.No other visual damage was observed.A document-based investigation evaluation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.There were no other reported complaints for this lot number.A review of the device history record revealed one non-conformance that involved two devices containing "foreign matter embedded in bag." this is relevant to the reported event, however due to the very small amount of non-conformance devices (2/150) and lack of other complaints associated to this lot, it is unlikely that there are any non-conformances in house or in field.Further, a review of manufacturing documentation confirmed that each device is 100% inspected for foreign matter after packaging.Based on inspection of the returned product and the provided information a definitive root cause cannot be established or reported at this time.The root cause is inconclusive due to the packaging being received opened.Possibly, it could be a manufacturing related non-conformance, however, it is also possible that the product was opened and then unintentionally contaminated during procedure preparation.For this reason, the device cannot be confirmed out of specification.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.

• Brand Name: DRAINAGE BAG CONNECTOR CONNECTING TUBE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7272066
• Report Number: 1820334-2018-00326
• Device Sequence Number: 16719635
• Product Code: GCJ
• UDI-Device Identifier: 00827002027916
• UDI-Public: (01)00827002027916(17)200825(10)8170964
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2018

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: CTU14.0-30
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 02/14/2018
• Supplement Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1