MAUDE Adverse Event Report: COOK INC PERFORMER INTRODUCER; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Codes	Leak/Splash (1354); Component Missing (2306)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	12/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event is currently under investigation.
Event or Problem Description
It was reported that the sealing at the proximal end of the catheter was missing.This occurrence led to a high-flow leakage of blood.The introducer was then changed.Per additional information received on (b)(6) 2017, the pharmacist reported the patient experienced a blood lost equivalent to that of a syringe of 10 ¿ 20 cc maximum.The patient was unharmed and did not require any additional procedures due to this occurrence.No additional information has been received.
Additional Manufacturer Narrative
Corrected data: (b)(4).A review of the complaint history, device history record, instructions for use (ifu), quality control, and visual inspection of the returned device was conducted during the investigation.There is no evidence to suggest the product was not made to specifications.Review of the device history record shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.One performer introducer was returned for investigation.Kinks were observed at 4.0 cm and 24.7 cm from the proximal end, as well as a 3 mm wrinkle at the distal end.The introducer is 44.9 cm in length.The hub seal was dislodged inside of the hub and the leak test failed.Instructions are in place to verify that the device is manufactured to specification.Since the device and package are inspected for defects prior to transport, it is unlikely that the device was nonconforming prior to the manufacturer's release.A definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.Blank fields on this form indicate the information is unknown, unavailable or unchanged.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6256418
• Report Number: 1820334-2017-00047
• Device Sequence Number: 865336
• Product Code: DYB
• UDI-Device Identifier: 00827002284388
• UDI-Public: (01)00827002284388(17)190801(10)7061537
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2017

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: RCFW-14.0-38-45-RB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2017
• Supplement Report FDA Received Date: 06/21/2017
• 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: Other