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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN TITANIUM PORT S/L; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 HICKMAN TITANIUM PORT S/L; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Catalog Number 0606100C
Device Problems Fracture (1260); Failure to Advance (2524); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/17/2020
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review 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.The catalog number identified has not been cleared in the us but is similar to the hickman titanium port s/l products that are cleared in the us.The pro code and 510 k number for the hickman titanium port s/l products are identified in procode and pma/510k.(expiry date: 10/2021).
 
Event Description
It was reported that during port placement procedure, the portion of the catheter inserted in the introducer sheath was allegedly short.It was further reported that sheath was allegedly damaged during the process.The procedure was completed using another device.There was no reported patient injury.
 
Event Description
It was reported that during port placement procedure, the portion of the catheter inserted in the introducer sheath was allegedly short.It was further reported that sheath was allegedly damaged during the process.The procedure was completed using another device.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 hickman titanium port s/l products that are cleared in the us.The pro code and 510 k number for the hickman titanium port s/l products are identified in d2 and g4.H10: manufacturing review: a complaint history review was performed.This is the third complaint reported for this product/lot number combination.The device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for these reports.Investigation summary: the device was not returned for evaluation.The investigation is inconclusive for the reported failure to advance and sheath damage.A definitive root cause could not be determined.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 provide 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.H3 other text : device not returned.
 
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Brand Name
HICKMAN TITANIUM PORT S/L
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 Key10911028
MDR Text Key218540659
Report Number3006260740-2020-20719
Device Sequence Number1
Product Code LJT
Combination Product (y/n)N
PMA/PMN Number
K050310
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0606100C
Device Lot NumberRECX3505
Was Device Available for Evaluation? No
Date Manufacturer Received06/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age11 MO
Patient Weight12
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