MAUDE Adverse Event Report: DATASCOPE FAIRFIELD NEONATAL SPECIALITY PACK - BEQ-TOP 22002; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 701062613

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/05/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.(b)(4).

Event Description

It was reported that prior to use of the neonatal speciality pack - beq-top 22002 custom tubing pack it was noted that the connectors were missing.The customer indicated that two 1/4 x 1/4 luers were deficient/missing when opened.They were able to cut in the missing connectors and the pack is assembled and planned to be used.This was noted prior to patient use and therefore there was no patient involvement.

Event Description

It was reported that prior to use of the neonatal speciality pack - beq-top 22002 custom tubing pack it was noted that the connectors were missing.The customer indicated that two 1/4 x 1/4 luers were deficient/missing when opened.They were able to cut in the missing connectors and the pack is assembled and planned to be used.This was noted prior to patient use and therefore there was no patient involvement.

Manufacturer Narrative

The product was not returned and so could not be evaluated.An investigation was performed concluding that the kit was built to specification.The line and connector that were reported missing were removed from the specification by the customer and was approved and released per cn.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The complaint could not be confirmed.(b)(4).

• Brand Name: NEONATAL SPECIALITY PACK - BEQ-TOP 22002
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 7919432
• MDR Text Key: 122194431
• Report Number: 2248146-2018-00558
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K08059223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/19/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2020
• Device Catalogue Number: 701062613
• Device Lot Number: 3000069806
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/05/2018
• Initial Date FDA Received: 09/28/2018
• Supplement Dates Manufacturer Received: 10/11/2018
• Supplement Dates FDA Received: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1