MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM LOW-PROFILE IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 0605510

Device Problems Component Missing (2306); No Apparent Adverse Event (3189); Missing Information (4053)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not 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.

Event Description

It was reported that during a port placement, the pressure indication was allegedly missing on the patient card.There was no reported patient injury.

Manufacturer Narrative

H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the investigation is inconclusive for the reported pressure indication missing on patient cards, as the device was not returned for evaluation.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 a port placement, the pressure indication was allegedly missing on the patient card.There was no reported patient injury.

Event Description

It was reported that during a port placement, the pressure indication was allegedly missing on the patient card.There was no reported patient injury.

Manufacturer Narrative

Additional information was received and the reportability was reassessed as malfunction.Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.The investigation is confirmed for the reported customer feedback issue as a report has been received but the description provided does not appear to relate to an adverse event.However, the investigation is unconfirmed for the reported pressure indication missing on patient card issue as for the non-power ports there were no pressure indication on the patient cards.Furthermore, a 25 psi maximum pressure was mentioned in the instruction for use.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.Instruction for use and it states that, precautions: do not use a syringe smaller than 10 ml! infusion pressure greater than 25 psi (172 kpa) may damage blood vessels and viscus and is not recommended.Do not use a syringe smaller than 10 ml.Flushing occluded catheters with small syringes can create excessive pressure within the port system.The current baw0734901 rev.0 states that, warning: do not use a syringe smaller than 10 ml.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.

• Brand Name: TITANIUM LOW-PROFILE IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F
• 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 Key: 11593780
• MDR Text Key: 243130712
• Report Number: 3006260740-2021-01054
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025969
• UDI-Public: (01)00801741025969
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K050310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2022

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 Number: 0605510
• Device Catalogue Number: 0605510
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 07/21/2021; 01/08/2022
• Supplement Dates FDA Received: 07/27/2021; 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other