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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Model Number 7707540
Device Problems Fluid/Blood Leak (1250); Fracture (1260); Material Perforation (2205)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/02/2021
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 05/2023).
 
Event Description
It was reported that during port placement procedure, there was allegedly perforation in the catheter.It was further reported that during flushing, the catheter allegedly leaked with saline solution.Reportedly, the physician did not use the port and the procedure was completed using another device.There was no reported patient injury.
 
Event Description
It was reported that during port placement procedure, there was allegedly perforation in the catheter.It was further reported that during flushing, the catheter allegedly leaked with saline solution.Reportedly, the physician did not use the port and 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: the investigation is inconclusive for the reported catheter damage and saline leakage issue as physical sample was not returned for evaluation.A definitive root cause could not be determined based on 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: 05/2023), 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.
 
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 x-port isp implantable port, one groshong catheter in two segments, one flushing connector attached to stylet, one introducer needle, one straight non-coring needle, one right-angle non-coring needle, one syringe, one j-tip guidewire in a guidewire hoop, one safety infusion set, and one tunneler were returned for evaluation.Visual, microscopic visual and functional evaluation were performed on the returned device.The investigation is confirmed for the reported fracture and fluid leak issues as a circumferential split was noted on the catheter just proximal to the 13cm depth mark.The edges of the circumferential split were noted to be smooth.Further during functional evaluation, leakage was noted from the circumferential split upon infusing the catheter.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.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 during port placement procedure, there was allegedly perforation in the catheter.It was further reported that during flushing, the catheter allegedly leaked with saline solution.Reportedly, the physician did not use the port and the procedure was completed using another device.There was no reported patient injury.
 
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Brand Name
X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 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
MDR Report Key11743819
MDR Text Key247945631
Report Number3006260740-2021-01582
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741027499
UDI-Public(01)00801741027499
Combination Product (y/n)N
PMA/PMN Number
K022983
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 10/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7707540
Device Catalogue Number7707540
Device Lot NumberREEX4051
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2021
Date Manufacturer Received10/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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