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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

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C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Catalog Number 9808560
Device Problems Fracture (1260); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2023
Event Type  malfunction  
Event Description
It was reported that sometimes a post port placement procedure, the catheter was allegedly broken.There was no reported patient injury.
 
Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.H11: section a through f ¿ the information provided 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 sometime post a port placement, the catheter was allegedly found to be broken.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport implantable port attached to a groshong catheter was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.A complete circumferential break was noted on the distal end of the attached catheter and on the proximal end of the distal catheter segment.The edges of the breaks on the distal end of the attached catheter were noted to be jagged and the surface was noted to be granular.A split was noted from the proximal end of the distal catheter segment.Therefore, the investigation is confirmed for the reported fracture and the identified material separation issues.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.The information provided 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.
 
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Brand Name
POWERPORT ISP M.R.I. 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 Key18418349
MDR Text Key331593423
Report Number3006260740-2023-05932
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741027512
UDI-Public(01)00801741027512
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K063377
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 03/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number9808560
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/12/2023
Initial Date FDA Received12/29/2023
Supplement Dates Manufacturer Received02/28/2024
Supplement Dates FDA Received03/06/2024
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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