Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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
Model Number 9808560
Device Problem Reflux within Device (1522)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2022
Event Type  malfunction  
Event Description
It was reported that during a port placement procedure, when the catheter was implanted, blood backflow occurred from the catheter.The procedure was completed using another device.There was no reported patient injury.
 
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 08/2023).
 
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 08/2023).
 
Event Description
It was reported that during a port placement procedure, when the catheter was implanted, blood backflow occurred from the catheter.The procedure was completed using another device.There was no reported patient injury.
 
Manufacturer Narrative
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: one groshong catheter was returned for evaluation.Gross visual, tactile and functional evaluations were performed on the returned device.The returned catheter appeared clean.During functional evaluation, the catheter was patent to infusion and aspiration without any issue.However, the investigation is inconclusive for the reported blood bleed back issue as the exact circumstances at the time of the reported event are unknown and the complete device including port was not returned for evaluation.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).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.
 
Event Description
It was reported that during a port placement procedure, when the catheter was implanted, blood backflow occurred from the catheter.The procedure was completed using another device.There was no reported patient injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key13591729
MDR Text Key286078384
Report Number3006260740-2022-00438
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 03/24/2022
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 Model Number9808560
Device Catalogue Number9808560
Device Lot NumberREFQ0305
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/27/2022
Initial Date FDA Received02/24/2022
Supplement Dates Manufacturer Received03/24/2022
Supplement Dates FDA Received03/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/10/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-