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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 TITANIUM IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Catalog Number 0602810CE
Device Problems Difficult to Flush (1251); Material Protrusion/Extrusion (2979)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/05/2022
Event Type  malfunction  
Event Description
It was reported that twenty days post port placement procedure, the septum allegedly dislodged.It was further reported that the port allegedly had difficulty while flushing.Reportedly patient experienced swelling at the time of saline injection and no intervention or medication was performed to treat the swelling.The port was removed and replaced.There was no reported patient injury.
 
Manufacturer Narrative
The catalog number identified in section d4 has not been cleared in the us but is similar to the titanium implantable port, groshong single-lumen, 8f products that are cleared in the us.The pro code and 510 k number for the titanium implantable port, groshong single-lumen, 8f products are identified in procode and pma/510kg4.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiration date: 08/2026).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 twenty days post port placement procedure, the septum allegedly dislodged.It was further reported that the port allegedly had difficulty while flushing.Reportedly patient experienced swelling at the time of saline injection and no intervention or medication was performed to treat the swelling.The port was removed and replaced.There was no reported patient injury.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the titanium implantable port, groshong single-lumen, 8f products that are cleared in the us.The pro code and 510 k number for the titanium implantable port, groshong single-lumen, 8f products are identified in d2 and g4.H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one titanium implantable port was returned for evaluation.Visual, microscopic visual and functional evaluation were performed on the returned device.The investigation is confirmed for the reported septum dislodgement issue as port septum was noted to be partially dislodged from the port body.Upon infusion, a leak from the dislodged port septum was noted upon infusion.However, the investigation is inconclusive for the reported difficult to flush issue and suction issue as the exact circumstances at the time of the reported event are unknown.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 (expiration date: 08/2026), g3 h11: h6 (method, result, conclusion) 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 : see h10.
 
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Brand Name
TITANIUM IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
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
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key15622297
MDR Text Key307109535
Report Number3006260740-2022-04031
Device Sequence Number1
Product Code LJT
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K050310
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
Report Date 02/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0602810CE
Device Lot NumberREFX2559
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/17/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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