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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN PORT SINGLE LUMEN; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 HICKMAN PORT SINGLE LUMEN; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Catalog Number 0603880C
Device Problems Restricted Flow rate (1248); Fluid/Blood Leak (1250)
Patient Problem Swelling/ Edema (4577)
Event Date 08/31/2021
Event Type  Injury  
Manufacturer Narrative
The catalog number identified has not been cleared in the us but is similar to the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f are cleared in the us.The pro code and 510 k number for the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f are identified.As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.Expiry date: 08/2023.
 
Event Description
It was reported that the six days post port placement in the right internal jugular vein, the port allegedly had low flow rate during infusion.It was further reported that the patient allegedly experienced swelling in the neck and chest.The port was removed from the right chest wall under local anesthesia.The current status of the patient is unknown.
 
Manufacturer Narrative
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, hickman single-lumen, 6.6f are cleared in the us.The pro code and 510 k number for the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f are identified in d2 and g4.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned for evaluation.One electronic photo was provided for review.The investigation is inconclusive for the reported restricted flow rate issue as the exact circumstances at the time of reported event was unknown and cannot be confirmed from the provided photo review.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.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.H10: d4 (expiry date: 08/2023), g3, h6 (method).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
It was reported that the six days post port placement in the right internal jugular vein, the port allegedly had low flow rate during infusion.It was further reported that the patient allegedly experienced swelling in the neck and chest.The port was removed from the right chest wall under local anesthesia.The current status of the patient is unknown.
 
Manufacturer Narrative
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, hickman single-lumen, 6.6f are cleared in the us.The pro code and 510 k number for the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f are identified in d2 and g4.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned for evaluation.One electronic photo was provided for review.The investigation is inconclusive for the reported restricted flow rate and fluid leak issues as the exact circumstances at the time of reported event was unknown and cannot be confirmed from the provided photo review.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.The 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: 08/2023), g3, h6 (device, method).H11: d6 (medical device explant date).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.H3 other text : device not returned.
 
Event Description
It was reported that the six days post port placement in the right internal jugular vein, the port allegedly had low flow rate during infusion.It was further reported that the patient allegedly experienced swelling in the neck and chest.The port was removed from the right chest wall under local anesthesia.The current status of the patient is unknown.
 
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Brand Name
HICKMAN PORT SINGLE LUMEN
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
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas 88780
MX   88780
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key12623768
MDR Text Key276141787
Report Number3006260740-2021-04346
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741111167
UDI-Public(01)00801741111167
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K924250
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 11/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0603880C
Device Lot NumberREEW3817
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age60 YR
Patient SexMale
Patient Weight65 KG
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