MAUDE Adverse Event Report: BARD ACCESS SYSTEMS M.R.I. ULTRA SLIMPORT IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 0605640

Device Problems Fracture (1260); Stretched (1601); Failure to Advance (2524)

Patient Problem Injury (2348)

Event Date 08/20/2020

Event Type  Injury  

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.The investigation of the reported event is currently underway.(expiry date - 03/2024).

Event Description

It was reported that during a port placement procedure, the guidewire allegedly stuck and failed to remove.It was further reported that the guide wire allegedly broke.The procedure was completed using another device.The patient status was unknown.

Event Description

It was reported that during a port placement procedure, the guidewire allegedly stuck in the troccard and failed to remove.It was further reported that the guide wire allegedly broken inside the trunk.The procedure was completed using another device.The patient status was unknown.

Manufacturer Narrative

H10: manufacturing review:a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary:one right-angle non-coring needle, one introducer needle and partial guide-wire were returned for evaluation.Visual, microscopic and dimensional evaluations were performed.Burrs were observed on the needle bevel.The investigation is confirmed for the reported failure to advance and fracture issue, as the guidewire appeared to be stuck within the introducer needle and only the partial guide-wire was returned extended out of the introducer hub.Also, the investigation is confirmed for unraveled material and stretched as the guidewire appeared unraveled and stretched just proximal to the needle hub.Based on the measurements recorded during sample evaluation and applicable drawings, the inner diameter of introducer needle is within tolerance and outer diameter measurements of unraveled guidewire is out of tolerance since it is completely broke and unraveled the tolerance limit might have deviated from the tolerance limit.A 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.H10: d4 (expiry date - 03/2024),h6(device: 1664).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.

• Brand Name: M.R.I. ULTRA SLIMPORT IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10566432
• MDR Text Key: 207910024
• Report Number: 3006260740-2020-03320
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025990
• UDI-Public: (01)00801741025990
• Combination Product (y/n): N
• PMA/PMN Number: K924250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

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
• Device Operator: Health Professional
• Device Model Number: 0605640
• Device Catalogue Number: 0605640
• Device Lot Number: REDX5047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 12/07/2020
• Supplement Dates FDA Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention