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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS M.R.I. LOW-PROFILE IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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BARD ACCESS SYSTEMS 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 Fracture (1260); Migration or Expulsion of Device (1395)
Patient Problem Injury (2348)
Event Date 08/11/2020
Event Type  Injury  
Manufacturer Narrative
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.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 products that are cleared in the us.The pro code and 510k number for the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products is identified.(expiry date: 01/2022).
 
Event Description
It was reported that approximately eight months post port placement procedure, the catheter allegedly fractured at the connection between the catheter and port body.It was further reported that the catheter migrated into the atrium.Reportedly the catheter was removed with medical intervention.The patient status was stable.
 
Manufacturer Narrative
Manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: one mri low-profile port with a catheter in two segments was returned for evaluation.Gross visual, microscopic visual and functional evaluations were performed.The investigation is confirmed for the reported catheter fracture and migration issue, as a complete circumferential break was noted approximately 1mm from the distal end of the cath-lock.A 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.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 products that are cleared in the us.The pro code and 510k number for the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products is identified in common device name and pma/510k.Expiry date: 01/2022, pma/510k.
 
Event Description
It was reported that approximately eight months post port placement procedure, the catheter allegedly fractured at the connection between the catheter and port body.It was further reported that the catheter migrated into the atrium.Reportedly the catheter was removed with medical intervention.The patient status was stable.
 
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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)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key10498790
MDR Text Key205895562
Report Number3006260740-2020-03183
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741111167
UDI-Public(01)00801741111167
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
Report Date 12/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0603880C
Device Lot NumberREDP3370
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2020
Initial Date Manufacturer Received 08/12/2020
Initial Date FDA Received09/07/2020
Supplement Dates Manufacturer Received11/30/2020
Supplement Dates FDA Received12/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age56 YR
Patient Weight60
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