MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0605420
Medical Device Problem Codes	Difficult to Flush (1251); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
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 image was provided for review.The investigation of the reported event is currently underway.(expiry date: 06/2024).
Event or Problem Description
It was reported that during port placement, the device allegedly had obstruction of flow.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the first complaint reported to date for this product and lot, therefore a device history record ¿review is not required.Investigation summary: one m.R.I.Implantable port, one introducer needle, one straight non-coring needle, one right-angle non-coring needle, one vein pick, one catheter lock, one guidewire in a guidewire hoop, one 8fr introducer peel-apart sheath and vessel dilator, one safety infusion set, and one tunneler were received for evaluation.Gross visual, microscopic visual and functional evaluation were performed on the retuned device.The investigation is inconclusive for the reported difficult to flush issue, as the exact circumstances during the reported event were unknown.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 or Problem Description
It was reported that during the preparation of port placement, the device allegedly had difficulties in flush.The procedure was completed using another device.There was no patient contact.

• Brand Name: M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F
• 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: 12257543
• Report Number: 3006260740-2021-03071
• Device Sequence Number: 4664433
• Product Code: LJT
• UDI-Device Identifier: 00801741025921
• UDI-Public: (01)00801741025921
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K873213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2021

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: 0605420
• Device Catalogue Number: 0605420
• Device Lot Number: REET3351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 09/05/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 09/07/2021
• 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