MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOME SUBQ PORT, GROSHONG; IMPLANTED PORT

Model Number	0602850
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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 a port catheter allegedly had a partial rupture, which disabled the catheter to be used.There was no patient contact.
Additional Manufacturer Narrative
As the lot number for the device was provided (on 8/27/2018), a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported that a port catheter allegedly had a partial rupture, which disabled the catheter from being used.There was no patient contact.
Event or Problem Description
It was reported that a port catheter allegedly had a partial rupture, which disabled the catheter from being used.There was no patient contact.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.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.Investigation summary: the product returned was one dome titanium port with 8 fr s/l groshong catheter.Visual, microscopic, tactual, and functional evaluations were performed.The complaint of a hole in the catheter is confirmed, and is found more specifically to be due to sharp instrument damage.Gross examination showed a detached 19.2 mm segment of distal tubing with a partially circumferential crack between the 16/17 cm depth markings, a detached 19.5 mm segment of interim tubing with 1.6 mm of interim tubing missing.The stretching open of the crack evidenced some local material stressing in the catheter membrane but showed clear sharp edges with a striated surface texture.Also observed was an apparent non-penetrative nick of the inside of the catheter walling.The definitive root cause could not be determined based upon available information.It is unknown if procedural issues contributed to the reported event.It is possible that this damage occurred during cutting the catheter to length during the procedure.

• Brand Name: DOME SUBQ PORT, GROSHONG
• Common Device Name: IMPLANTED PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7807497
• Report Number: 3006260740-2018-02170
• Device Sequence Number: 1573851
• Product Code: LJT
• UDI-Device Identifier: 00801741025754
• UDI-Public: (01)00801741025754
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K880571
• 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,Followup
• Report Date (Section B): 01/08/2019

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: 0602850
• Device Catalogue Number: 0602850
• Device Lot Number: REBV0383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 08/27/2018; 12/14/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 09/21/2018; 01/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1