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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS M.R.I. LOW-PROFILE IMPLANTABLE PORT, HICKMEN SINGLE-LUMEN, 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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BARD ACCESS SYSTEMS M.R.I. LOW-PROFILE IMPLANTABLE PORT, HICKMEN SINGLE-LUMEN, 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Catalog Number 0603880C
Device Problems Fracture (1260); Suction Problem (2170); Failure to Infuse (2340)
Patient Problems Edema (1820); Hemorrhage/Bleeding (1888)
Event Date 06/15/2020
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiry date (07/2022).The catalog number identified in section has not been cleared in the us but is similar to the m.R.I.Low-profile implantable port, hickmen single-lumen, 6.6f products that are cleared in the us.The pro code and 510k number for the m.R.I.Low-profile implantable port, hickmen single-lumen, 6.6f products is identified.
 
Event Description
It was reported that approximately twenty days after port implantation, the nurse allegedly able to withdraw a very small quantity of brown colored blood.It was further reported that the injection was stopped as the skin around the port was slightly swollen.In addition, a check ct examination was perform for possible rupture of infusion port catheter and transferred to another facility.The patient's current status was unknown.
 
Event Description
It was reported that approximately twenty days after port implantation, the nurse allegedly able to withdraw a very small quantity of brown colored blood.It was further reported that the injection was stopped as the skin around the port was slightly swollen.In addition, a check ct examination was perform for possible rupture of infusion port catheter and transferred to another facility.The patient's current status was unknown.
 
Manufacturer Narrative
H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: the sample was not returned.The investigation is inconclusive for the reported fracture, failure to infuse and aspirate issue, as the device was not returned for evaluation.A definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 07/2022),g4.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the m.R.I.Low-profile implantable port, hickmen single-lumen, 6.6f products that are cleared in the us.The pro code and 510k number for the m.R.I.Low-profile implantable port, hickmen single-lumen, 6.6f products is identified in d2 and g5.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
M.R.I. LOW-PROFILE IMPLANTABLE PORT, HICKMEN SINGLE-LUMEN, 6.6F
Type of Device
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key10565663
MDR Text Key207891333
Report Number3006260740-2020-03317
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741111167
UDI-Public(01)00801741111167
Combination Product (y/n)N
PMA/PMN Number
K924250
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0603880C
Device Lot NumberREDV3027
Was Device Available for Evaluation? No
Date Manufacturer Received12/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age65 YR
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