MAUDE Adverse Event Report: COOK INC COOK ECHOTIP AMNIOCENTESIS NEEDLE; HIO SAMPLER, AMNIOTIC FLUID (AMNIOCENTESIS TRAY)

Catalog Number	J-DAN-201501
Medical Device Problem Code	Difficult To Position (1467)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2017
Type of Reportable Event	Malfunction
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
The user facility reported during an amniocentesis procedure, the cook echo tip amniocentesis needle could not be seen under the ultrasound during the procedure.Additional information that was received was the needle was more flexible and not visible.There was no report of any adverse effects or consequences to the patient due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the investigation included a review of complaint history, the device history record, drawings, manufacturing instructions, and specifications.The actual needles used in this complaint were not returned.A visual inspection and functional testing of returned unused product was conducted.Three unopened packages containing a j-dan-201501 were returned for investigation.With the assistance of the senior engineer, research, the devices were checked with the sonosite l38/10-5 ultrasound probe/¿l38/10-5 mhz 38mm linear array transducer.All three needles visibility was clear and bright in the ultrasound.The device history record review found there are no non-conformances associated with the complaint device lot number 7872604.A review of complaint history shows this to be the only complaint received associated with complaint lot number 7872604.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.Based on the provided information a definitive root cause cannot be established for the report of ¿the needle could not be seen during the amniocentesis procedure¿.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: COOK ECHOTIP AMNIOCENTESIS NEEDLE
• Common Device Name: HIO SAMPLER, AMNIOTIC FLUID (AMNIOCENTESIS TRAY)
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7132627
• Report Number: 1820334-2017-04338
• Device Sequence Number: 11090396
• Product Code: HIO
• UDI-Device Identifier: 00827002162891
• UDI-Public: (01)00827002162891(17)200428(10)7872604
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2018

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: J-DAN-201501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1