MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 210 REPAIR 1.6MM-WHITE; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0601630
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported malfunction, the device was returned to bd for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0601630 port & catheter allegedly experienced a fluid leak.This information was received from one source.The malfunction did not involve a patient.Patient age, weight, and gender were not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0601630 port & catheter allegedly experienced a fluid leak.This information was received from one source.The malfunction did not involve a patient.Patient age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number was provided and a lot history review was performed.The investigation confirmed for the alleged leak.A definitive root cause could not be established.The device is labeled for single use.H10: g4 h11: h6 (results, conclusion) 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: 210 REPAIR 1.6MM-WHITE
• 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: 9205651
• Report Number: 3006260740-2019-03114
• Device Sequence Number: 11410452
• Product Code: LJS
• UDI-Device Identifier: 00801741036408
• UDI-Public: (01)00801741036408
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

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: No Information
• Device Model Number: 0601630
• Device Catalogue Number: 0601630
• Device Lot Number: RECS1775
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 01/06/2020
• Patient Sequence Number: 1