MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MRI L/P PORT W/GROS 7.0F; IMPLANTABLE PORT

Model Number	0603870
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.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.The investigation of the reported event is currently underway.The information provided by bard 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 bard.
Event or Problem Description
It was reported that during port catheter insertion, there was alleged swelling and flexing of the tunneling mandrel.It was further reported that the tunneler was unable to be placed.There was no reported patient injury.
Event or Problem Description
It was reported that during port catheter insertion, there was alleged swelling and flexing of the tunneling mandrel.It was further reported that the tunneler was unable to be placed.There was no reported patient injury.
Additional Manufacturer Narrative
Per the lot history review, this is the 1st complaint reported for this lot number and issue to date.The quantity affected is 1 units.Based upon the severity level and lot quantity, a device history record review is not required.However, the dhr was requested to review manufacturing records.The device history records have been reviewed with special attention to the subassemblies, material review reports, raw material testing, manufacturing process, and quality control inspection.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.The devices returned were found to be two 7 fr macrointroducers with both dilator and sheath.This complaint addresses sample 2, whereas complaint (b)(4) addresses sample 1.Visual, microscopic, and tactile evaluations were performed.The complaint of tunneler (introducer) damage is confirmed.The introducer manifested mechanical damage to the tip of the dilator such that the distal orifice was no longer circular.The sheath was kinked in several places and the sheath tip was severely indented at one point and otherwise deformed and blunted through about half of its circumference.No evidence of poor tipping on this sheath was found.The root cause cannot be determined based upon available information.It is unknown if procedural issues contributed to the reported event; the damage found on the dilator and sheath tips and the report of difficulty of insertion are consistent with resistance during insertion, such as from poor insertion technique.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.(b)(4).

• Brand Name: MRI L/P PORT W/GROS 7.0F
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7844397
• Report Number: 3006260740-2018-02343
• Device Sequence Number: 1981522
• Product Code: LJT
• UDI-Device Identifier: 00801741025839
• UDI-Public: (01)00801741025839
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K924250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2018

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: 0603870
• Device Catalogue Number: 0603870
• Device Lot Number: REBX1612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 12/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 89