MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 203 REPAIR 1.0MM-WHITE; PORT AND CATHETER ACCESSORIES

Model Number	0601620
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the one reported information, the device was returned to bd and evaluated.The lot number was provided for the one malfunction; therefore, a lot history review is currently being performed.The investigation identified a break for the returned device.Based upon the available information, the definitive root cause for this event is unknown.The devices are labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0601620 port and catheter accessories allegedly experienced a break.This information was received from one source.Of the one break malfunction, one involved a patient with no patient consequences.There was no provided patient information.
Additional Manufacturer Narrative
H10: the lot number for the device was provided; therefore, a lot history review was performed.The device was returned for evaluation.The investigation confirmed for fracture.A definitive root cause could not be determined.The devices are labeled for single use.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.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0601620 port and catheter accessories allegedly experienced a break.This information was received from one source.Of the one break malfunction, one involved a patient with no patient consequences.There was no provided patient information.

• Brand Name: 203 REPAIR 1.0MM-WHITE
• Common Device Name: PORT AND CATHETER ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9591056
• Report Number: 3006260740-2020-00084
• Device Sequence Number: 11574223
• Product Code: LJS
• UDI-Device Identifier: 00801741074479
• UDI-Public: (01)00801741074479
• 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): 07/13/2020

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: 0601620
• Device Catalogue Number: 0601620
• Device Lot Number: RECX0769
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 07/13/2020
• Patient Sequence Number: 1