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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN PORT S/L; IMPLANTABLE PORT
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BARD ACCESS SYSTEMS HICKMAN PORT S/L; IMPLANTABLE PORT Back to Search Results
Catalog Number 0603840CE
Device Problems Unsealed Device Packaging (1444); Peeled/Delaminated (1454); Difficult to Open or Remove Packaging Material (2922)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The lot number was provided, therefore a lot history review could be performed.The sample was returned and a photo was provided to the manufacturer for evaluation.The investigation identified the inner package covering was opened.The company is still investigating the issue at this time.The device is labeled for single use.The catalog number identified has not been cleared in the us, but is similar to the hickman port s/l products that are cleared in the us.The pro code for the hickman port s/l products is identified.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model 0603840ce implantable port allegedly experienced unsealed device packaging.This information was received from one source.This malfunction did not involve patient.Age, weight, and gender of the patient was not provided.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model 0603840ce implantable port allegedly experienced unsealed device packaging.This information was received from one source.This malfunction did not involve patient.Age, weight, and gender of the patient was not provided.
 
Manufacturer Narrative
H10: the lot number was provided, therefore a lot history review was performed.The sample was returned and a photo was provided to the manufacturer for evaluation.The investigation is confirmed for the package seal issue as the inner package covering was opened and shredded and delaminated.The company is still investigating the issue at this time.The device is labeled for single use.H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the hickman port s/l products that are cleared in the us.The pro code for the hickman port s/l products is identified in d2.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model 0603840ce implantable port allegedly experienced peeled / delaminated and difficult to open or remove packaging material.This information was received from one source.This malfunction did not involve patient.Age, weight, and gender of the patient was not provided.
 
Manufacturer Narrative
H10: the lot number was provided, therefore a lot history review was performed.The sample was returned and a photo was provided to the manufacturer for evaluation.The investigation is confirmed for peeled/delaminated issue and difficult to open packaging material.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the hickman port s/l products that are cleared in the us.The pro code for the hickman port s/l products is identified in d2.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
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Brand Name
HICKMAN PORT S/L
Type of Device
IMPLANTABLE PORT
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key10283218
MDR Text Key199118424
Report Number3006260740-2020-02463
Device Sequence Number1
Product Code LJT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup,Followup
Report Date 01/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number0603840CE
Device Lot NumberRECV2596
Date Manufacturer Received12/31/2020
Patient Sequence Number1
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