MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ADULT MRI W/6FR CHX CTOW; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0607174
Medical Device Problem Codes	Fracture (1260); Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	05/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending; however, photos have been provided.The investigation of the reported event is currently underway.(expiration date: 01/2024).
Event or Problem Description
It was reported during a port implantation, the catheter allegedly broke.It was further reported that the distal end of the catheter is displaced towards the superior vena cava/atrium.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review was conducted and it was determined that a device history record review was not required.Investigation summary: one chornoflex catheter and one flushing connector were returned for evaluation.The flushing connector was attached to the proximal end of the catheter.A complete circumferential break was noted at the distal end of the catheter segment; the distal catheter segment was not returned.Blood was noted throughout.One electronic photo was reviewed.The photo shows a catheter with blood and residue noted.The winged flushing connector set is also inserted into one end of the catheter.The catheter is being held by a person wearing latex gloves.Therefore, the investigation is confirmed for the alleged catheter break as the break surface was uneven and did not appear to have been cut.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.H10: d4 (expiration date: 01/2024),g4.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 during a port implantation, the catheter allegedly broke.It was further reported that the distal end of the catheter is displaced towards the superior vena cava / atrium.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: ADULT MRI W/6FR CHX CTOW
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10178173
• Report Number: 3006260740-2020-02180
• Device Sequence Number: 2560813
• Product Code: LJT
• UDI-Device Identifier: 00801741026102
• UDI-Public: (01)00801741026102
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0607174
• Device Catalogue Number: 0607174
• Device Lot Number: REDS0382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 09/02/2020
• 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: Required Intervention