MAUDE Adverse Event Report: NAVILYST MEDICAL NAVILYST MEDICAL / PERCEPTOR; TRANSDUCER, BLOOD PRESSURE

Catalog Number H965700300211

Device Problem Hole In Material (1293)

Patient Problem No Patient Involvement (2645)

Event Date 01/14/2015

Event Type  malfunction  

Event Description

As reported by navilyst medical's distributor in (b)(4), a pouch containing a disposable blood pressure monitoring transducer was noted to have a small hole in the pouch, thereby compromising sterility.The device was never set to an end user, and has been returned to navilyst medical.

Manufacturer Narrative

The reported device has been returned to navilyst medical.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).

Manufacturer Narrative

A review of the device history records was performed for the reported packaging lot for any deviations related to the reported defect of the complaint.The review confirms that the lot met all material, assembly and performance specifications.The angiodynamics september 2015 complaint report was reviewed for the product family of preceptor/dt and the failure mode, "pouch torn/holes." no adverse trends were identified.The returned sample was visually inspected and the hole in the pouch was confirmed.A close-up examination of the pouch indicated that the hole was caused by something from the outside pushing into the pouch.The pouch size is appropriate for the device and the number of pouches per inner box is also appropriate.Although the returned sample did not have a nipro label applied to the pouch, as part of the receiving process at nipro all pouches are removed from their inner boxes and a nipro label (in japanese) is applied to each pouch and inner box.Additional handling may occur if product is 100 percent visually inspected.The pouches are then re-boxed into the inner boxes by the nipro warehouse employees.Although the cause of the hole in the tyvek of the pouch was unable to be determined, potential factors contributing to the damage include: handling of the pouches as they are placed in the inner boxes; handling during transit to nipro warehouse; handling at nipro during the labeling/inspection and re-boxing process.All pouches are 100 percent inspected per angiodynamics procedures during the sealing and final box processes.The directions for use (dfu) included with the kits contain the following warning: "contents supplied sterile using an ethylene oxide (eo) process.Do not use if sterile barrier is damaged." all packaging employees have been made aware of this complaint in order to improve their awareness of the defect and to improve the probability of identifying the defect in the future.(b)(4).

• Brand Name: NAVILYST MEDICAL / PERCEPTOR
• Type of Device: TRANSDUCER, BLOOD PRESSURE
• Manufacturer (Section D): NAVILYST MEDICAL; glens falls NY
• Manufacturer (Section G): NAVILYST MEDICAL; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: michael duerr ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424571
• MDR Report Key: 4541036
• MDR Text Key: 16895673
• Report Number: 1317056-2015-00054
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K910764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: H965700300211
• Device Lot Number: 4821963
• Other Device ID Number: PERCEPTOR DT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/29/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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