MAUDE Adverse Event Report: DATASCOPE CORP. ADULT CPB PACK; CARDIOPULMONARY DEVICE

Model Number BO-TOP 19100

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2014

Event Type  malfunction  

Event Description

It was reported that there was damage to the packaging.No pt was involved.Related to mfr reports#: 2248146-2014-00300, 2248146-2014-00302.

Manufacturer Narrative

An investigation was performed on returned product and it was found that the location of the damage was consistent with the location of the manifold and reservoir components found in this kit.It was also found that these components were dislodged and packaging welds used to secure these components were broken.In order to further determine if this damage was caused prior to shipping, the remaining units in stock were inspected and no damage was found.Based on the results of the investigation and the description of the damage, it was determined that these issues were caused by rough handling of the device during shipping.In order to provide better protection and prevent future issues, an agreement was made with the customer, which will facilitate the shipment of multiple units in palletized form.Additionally, shipments will be labeled as "fragile life support device", prior to shipping to ensure they are handled in the correct manner.(b)(4).

• Brand Name: ADULT CPB PACK
• Type of Device: CARDIOPULMONARY DEVICE
• Manufacturer (Section D): DATASCOPE CORP.; fairfield NJ
• Manufacturer Contact: jason sousa ; 15 law dr.; fairfield, NJ 07004 ; 9737097256
• MDR Report Key: 4063116
• MDR Text Key: 16990813
• Report Number: 2248146-2014-00301
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2016
• Device Model Number: BO-TOP 19100
• Device Catalogue Number: 701052579
• Device Lot Number: 16902-06
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/22/2014
• Date Manufacturer Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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