MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / NAVILYST MEDICAL; STOPCOCK

Catalog Number H965700550091

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem Not Applicable (3189)

Event Date 11/10/2017

Event Type  malfunction  

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 complaint report was reviewed for the stopcock product family and the failure mode,"package - hole/perforated." no adverse trends were identified.The returned sample was visually inspected and the hole in the stopcock pouch was confirmed.The root cause of the hole is that the handle from the stopcock presses outward against the tyvek.As part of the receiving process at nipro (the distributor in (b)(4)), all pouched products are removed from their inner boxes and a nipro label (in (b)(4)) is applied to each pouch and inner box.Additional handling may occur if product is 100% visually inspected.The pouched product is then re-boxed into the inner box by the nipro warehouse employees.The hole in the tyvek was likely caused by the handle of the stopcock in the pouch, however, what caused the handle to be pushed against the tyvek in a manner that resulted in a hole cannot be determined.A recent revision to the packaging materials for the stopcocks included a change to a deeper inner box with the intention of reducing the chances of over-crowding of product within the box.The lot of product from this reported event was packaged after implementation of this change.Potential contributing factors to the pouch damage include: handling during transit to nipro warehouse.Handling during nipro labeling/inspection and re-boxing process.All pouches are 100% inspected per angiodynamics procedures during the sealing and final box processes.Employees involved in the packaging/final boxing of the reported lot of product have been made aware of this complaint.The directions for use (dfu) packaged with the stopcocks contain the following warning: "contents supplied sterile using an ethylene oxide (eo) process.Do not use if sterile barrier is damaged." (b)(4).

Event Description

As reported by angiodynamics' distributor in (b)(4), in the distributor's warehouse a small hole was found in the tyvek portion of a stopcock pouch, breaching the sterility.The device had not been provided to a hospital and was returned to angiodynamics for evaluation.

• Brand Name: ANGIODYNAMICS / NAVILYST MEDICAL
• Type of Device: STOPCOCK
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 7064379
• MDR Text Key: 93695424
• Report Number: 1317056-2017-00101
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: H965700550091
• UDI-Public: H965700550091
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K842829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: H965700550091
• Device Lot Number: 5231868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1