MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 VACCESS CT LOW-PROFILE POWER-INJECTABLE IMPLANTABLE PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	7360001
Medical Device Problem Code	Difficult to Flush (1251)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional 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 as well as images were provided for review.The investigation of the reported event is currently underway.(expiry date: 07/2022).
Event or Problem Description
It was reported that post port placement, it was allegedly unable to flush the port.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this lot number and the lot met all release criteria.A device history record review is not required.Investigation summary: one vaccess ct low-profile port attached to a catheter was returned for evaluation.Gross visual, microscopic visual and functional evaluations were performed.An in-house syringe was attached to a safety infusion set and the non-coring needle was inserted into the port septum.The port body with attached catheter segment was patent to infusion and aspiration without issue.Hydrostatic pressure was applied by clamping the distal end of the catheter segment while infusing to observe for leaks; no leaks were noted.However, the investigation is inconclusive for the reported unable to flush, as the exact circumstances at the time of the reported event are unknown, and the reported event could not be reproduced in the lab.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.H10: d4 (expiry date: 07/2022).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 or Problem Description
It was reported that post port placement, it was allegedly unable to flush the port.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this lot number and the lot met all release criteria.A device history record review is not required.Investigation summary: one vaccess ct low-profile port attached to a catheter was returned for evaluation.Gross visual, microscopic visual and functional evaluations were performed.An in-house syringe was attached to a safety infusion set and the non-coring needle was inserted into the port septum.The port body with attached catheter segment was patent to infusion and aspiration without issue.Hydrostatic pressure was applied by clamping the distal end of the catheter segment while infusing to observe for leaks; no leaks were noted.However, the investigation is inconclusive for the reported unable to flush, as the exact circumstances at the time of the reported event are unknown, and the reported event could not be reproduced in the lab.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.H10: d4 (expiry date: 07/2022), 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 or Problem Description
It was reported that post port placement, it was allegedly unable to flush the port.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: VACCESS CT LOW-PROFILE POWER-INJECTABLE IMPLANTABLE PORT
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11341609
• Report Number: 3006260740-2021-00374
• Device Sequence Number: 13635567
• Product Code: LJT
• UDI-Device Identifier: 00801741027444
• UDI-Public: (01)00801741027444
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2021

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
• Operator of Device: Health Professional
• Device Model Number: 7360001
• Device Catalogue Number: 7360001
• Device Lot Number: REEW2270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 07/15/2021; 07/23/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 07/17/2021; 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 6 MO
• Patient Weight: 9