MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TITANIUM LOW PROFILE PORT, GROSHONG S/L- JAPAN ONLY; IMPLANTABLE PORT

Catalog Number 0606150J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Photos were provided for review.The device has not been returned to the manufacturer for evaluation.As the lot number for the device was not provided, a review of the device history records has not been performed.The investigation of the reported event is currently underway.(expiration date: 10/2023).

Event Description

It was reported that immediately post port device implant, the patient lost consciousness and expired.Reportedly, the catheter was removed.

Event Description

It was reported that immediately post port device implant, the patient lost consciousness and expired.Reportedly, the catheter was removed.

Manufacturer Narrative

Catalog number identified has not been cleared in the us; however, the devices are similar to the groshong s/l titanium low profile port products that are cleared in the us.The pro code for the products is identified in d2.Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one groshong catheter with a pre-inserted stylet, one guidewire with j-tip and one vessel dilator were returned for evaluation.A slight bend was noted on the dilator as well as minor scuffs on the tip.The dilator was still functional and no anomalies were noted that would put the device out of specification.One electronic photo was evaluated.The photo shows a catheter attached to a syringe, a dilator, and a guidewire along with the device information documentation are laying on top of some brown paper towels.No anomalies can be noted.The investigation is unconfirmed, as no deficiencies with the device were reported or found upon evaluation.The definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural issues contributed to the reported event.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.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: TITANIUM LOW PROFILE PORT, GROSHONG S/L- JAPAN ONLY
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9881221
• MDR Text Key: 184979015
• Report Number: 3006260740-2020-01059
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098253
• UDI-Public: (01)00801741098253
• Combination Product (y/n): N
• 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: 08/24/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0606150J
• Device Lot Number: REDP0054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/25/2020
• Supplement Dates Manufacturer Received: 08/20/2020
• Supplement Dates FDA Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other