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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. LOW-PROFILE IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 M.R.I. LOW-PROFILE IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Catalog Number 0603880C
Device Problems Difficult to Insert (1316); Deformation Due to Compressive Stress (2889); Device-Device Incompatibility (2919); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/05/2020
Event Type  malfunction  
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.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 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 is identified in d2 and g5.(expiry date: 09/2022) 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
It was reported that during a port placement procedure, the catheter sheath was allegedly failed to insert over guidewire.It was further reported that tip allegedly deformed.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the fourth complaint reported for this product/lot number combination.However, device history record review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.The investigation is inconclusive for the reported difficult to insert and tip deformation issue.A definitive root cause could not be determined.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: 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 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 is identified in d2 and g4.H10: d4 (expiry date: 09/2022), g3.H11: b3, h6 (device).H11: section a through f ¿ the information provide by bd represents all 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.H3 other text : device not returned.
 
Event Description
It was reported that during a port placement procedure, the catheter sheath was allegedly failed to insert over guidewire.It was further reported that tip allegedly deformed.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: a complaint history review was performed.This is the fourth complaint reported for this lot number.A device history record review was performed and the lot met all release criteria.Investigation summary: the sample was not returned to the manufacturer for evaluation.Therefore, the investigation is inconclusive for the reported difficult to insert and tip deformation issue.A definitive root cause could not be determined based upon the 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.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 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 is identified in d2 and g4.The information provide by bd represents all 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
It was reported that during a port placement procedure, the catheter sheath was allegedly failed to insert over guidewire.It was further reported that tip allegedly deformed.There was no reported patient injury.
 
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Brand Name
M.R.I. LOW-PROFILE IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 6.6F
Type of Device
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
MDR Report Key11138513
MDR Text Key225725294
Report Number3006260740-2021-00008
Device Sequence Number1
Product Code LJT
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,Followup
Report Date 08/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0603880C
Device Lot NumberREDX4249
Was Device Available for Evaluation? No
Date Manufacturer Received08/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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