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

Catalog Number J-DAN-201501

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2017

Event Type  malfunction  

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 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.

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
• Type of Device: HIO SAMPLER, AMNIOTIC FLUID (AMNIOCENTESIS TRAY)
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7132627
• MDR Text Key: 95534826
• Report Number: 1820334-2017-04338
• Device Sequence Number: 1
• Product Code: HIO
• UDI-Device Identifier: 00827002162891
• UDI-Public: (01)00827002162891(17)200428(10)7872604
• Combination Product (y/n): N
• Reporter Country Code: GR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-DAN-201501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1