MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS ACCESS SET; DYB INTRODUCER, CATHETER

Catalog Number	MPIS-501-NT-U-SST
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) number: pre-amendment.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
It was reported, a hair was noted within the sterile package of a micropuncture transitionless access set prior to use.The complaint device was not used.A different set was opened and used to begin the procedure.According to the initial reporter, no patient adverse events were experienced.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, quality control, and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device confirmed the presence of a long, hair-like fiber inside the product's packaging.Additionally, a document based investigation evaluation was performed.There is evidence to suggest the product was not made to specifications.A review of the device history record showed two nonconforming events which could contribute to this failure mode.Although the nonconformances are related to the complaint failure mode, the affected units were reworked.It should be noted there were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, a definitive root cause has been determined to be a manufacturing issue; however, appropriate measures have been initiated to address this failure mode.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, quality control, and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device confirmed the presence of a long, hair-like fiber inside the product's packaging.Additionally, a document based investigation evaluation was performed.There is evidence to suggest the product was not made to specifications.A review of the device history record showed two nonconforming events which could contribute to this failure mode.Although the nonconformances are related to the complaint failure mode, the affected units were reworked.It should be noted there were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, a definitive root cause has been determined to be a manufacturing issue; however, appropriate measures have been initiated to address this failure mode.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: MICROPUNCTURE TRANSITIONLESS ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7598108
• Report Number: 1820334-2018-01701
• Device Sequence Number: 178525
• Product Code: DYB
• UDI-Device Identifier: 00827002438712
• UDI-Public: (01)00827002438712(17)210424(10)8836873
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 08/07/2018

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 Catalogue Number: MPIS-501-NT-U-SST
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1