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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD BEQ-TOP 5208 ECC SMALL CUSTOM TUBING PACK; TUBING, PUMP, CARDIOPULMONARY BYPASS
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DATASCOPE FAIRFIELD BEQ-TOP 5208 ECC SMALL CUSTOM TUBING PACK; TUBING, PUMP, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 701067350
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 04/09/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).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 bioline and softline sticker shown on package but no softline was in the components of the custom tubing pack.This was identified prior to patient use and therefore there was no patient involvement.The date of the event is unknown.
 
Manufacturer Narrative
Additional information: date of event changed from: blank to: (b)(6) 2018.(b)(4).
 
Event Description
It was reported that bioline and softline sticker shown on package but no softline was in the components of the custom tubing pack.This was identified prior to patient use and therefore there was no patient involvement.
 
Event Description
It was reported that bioline and softline sticker shown on package but no softline was in the components of the custom tubing pack.This was identified prior to patient use and therefore there was no patient involvement.The date of the event is unknown.
 
Manufacturer Narrative
Although the customer did not want to return the product for evaluation per their response to our second good faith effort, it is not needed to determine if this complaint is confirmed because a picture of the product packaging/labeling was provided.A review of the provided picture indicated the product type, lot, and labeling in question.Manufacturing received the picture of the tyvek lid.The manufacturing records for the kit indicate it was built to the drawing and the softline label was required to be and was placed on this kit, since there is a softline component included in this kit.A lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.We are unable to confirm the reported problem.(b)(4).
 
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Brand Name
BEQ-TOP 5208 ECC SMALL CUSTOM TUBING PACK
Type of Device
TUBING, PUMP, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key7489944
MDR Text Key107590239
Report Number2248146-2018-00308
Device Sequence Number1
Product Code DWE
Combination Product (y/n)N
PMA/PMN Number
K08059223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 06/01/2018
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 Date12/20/2019
Device Catalogue Number701067350
Device Lot Number3000065084
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/09/2018
Initial Date FDA Received05/07/2018
Supplement Dates Manufacturer Received05/25/2018
06/01/2018
Supplement Dates FDA Received05/31/2018
06/01/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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