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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC ECONOMY SOFT TISSUE BIOPSY TRAY; TRAY, SURGICAL, NEEDLE
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CAREFUSION, INC ECONOMY SOFT TISSUE BIOPSY TRAY; TRAY, SURGICAL, NEEDLE Back to Search Results
Catalog Number 4380
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Patient Involvement (2645)
Event Date 05/29/2019
Event Type  malfunction  
Manufacturer Narrative
Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
 
Event Description
Damaged/defective sealed.2-july-2019 add'l information: per clarification with customer, the seal is not completely open, just at the right bottom corner.The defect part were found at distributor site, hence they are rejecting this product prior sending to customer as there is possibilities missing item or damage when reach customer.(b)(4).
 
Event Description
Damaged/defective sealed.2-july-2019 add'l information: per clarification with customer, the seal is not completely open, just at the right bottom corner.The defect part were found at distributor site, hence they are rejecting this product prior sending to customer as there is possibilities missing item or damage when reach customer.Lzak.
 
Manufacturer Narrative
Pr (b)(4) follow up emdr for device evaluation.A photo was received for evaluation.Customer provided photographs confirmed the failure mode (package seal integrity poor).Visual analysis of the provided photographs shows a corner which appears to have been pulled.The exposed seal (corner which has been pulled) demonstrates no evidence of a defect.The seal demonstrates no folds or creases and the photograph provides evidence of an initial complete seal.Based on the evaluation of the customer photos, there is no evidence to suggest a manufacturing defect contributed to the open seal.The visual evidence suggests the seal was inadvertently opened by someone pulling on the corner of the packaging causing the top and bottom webs to separate.A review of the device history record shows that all inspection results passed per the dhr process and no anomalies were noticed during production.Review of the pull testing data for the multivac sealing operation for the date the affected lot (lot 0001257428) was sealed demonstrated the seal pull test values were well above the lower specification limit.This data suggests the sealing operation was functioning correctly and producing acceptable seals per manufacturing work processes.Based on the investigation results, no contribution could be identified from any of the factors noted above.Based on the investigation results, the most likely source of the identified defect was damage during the distribution process prior to receipt by the customer or by the receiving personnel when trying to remove the affected unit from the shipping case.The investigation did not identify any probable root cause associated with the manufacturing of the affected unit or lot.The investigation was not able to identify a source for the damage since the specific conditions of the distribution process was not known by the investigation and could not be retrieved.Since a probable root cause could not be identified for the identified defect, the investigation was not able to identify any corrective or preventive actions for this complaint.The complaint will be added to the complaint management process and will be tracked and trended for future occurrences.
 
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Brand Name
ECONOMY SOFT TISSUE BIOPSY TRAY
Type of Device
TRAY, SURGICAL, NEEDLE
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
MDR Report Key8754423
MDR Text Key209554497
Report Number1625685-2019-00063
Device Sequence Number1
Product Code FSH
Combination Product (y/n)N
PMA/PMN Number
K813338
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number4380
Device Lot Number0001257428
Date Manufacturer Received08/05/2019
Patient Sequence Number1
Patient Outcome(s) Other;
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