MAUDE Adverse Event Report: BARD ACCESS SYSTEMS REPAIR, WHITE ADAPTER LEG; PORT AND CATHETER ACCESSORIES

Model Number	0601680
Medical Device Problem Codes	Stretched (1601); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review will be performed.The device for this malfunction has been returned to the manufacturer for evaluation.The investigation of the reported malfunction is currently underway.The device is labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model 0601680 port and catheter accessory allegedly experienced material deformation.This information was received from one source.The malfunction involved one patient with no patient consequences.The age and weight of the male patient were not provided.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review will be performed.The device for this malfunction has been returned to the manufacturer for evaluation.The investigation of the reported malfunction is currently underway.The device is labeled for single use.H11: b5 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 0601680 port and catheter accessory allegedly experienced material deformation.This information was received from one source.The malfunction involved one patient with no patient consequences.The age and weight of the male patient were not provided.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review will be performed.The device for this malfunction has been returned to the manufacturer for evaluation.The evaluation identified material deformation.Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.H10: g4 h11: h2, h6 (results and 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.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0601680 port and catheter accessory allegedly experienced material deformation.This information was received from one source.The malfunction involved one patient with no patient consequences.The age and weight of the male patient were not provided.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The device for this malfunction has been returned to the manufacturer for evaluation.The investigation confirmed the malfunction was material deformation.Based upon the available information, a definitive root cause was unknown.The device was labeled for single use.H10: g4 h11: g1, h2, 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.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0601680 port and catheter accessory allegedly experienced material deformation.This information was received from one source.The malfunction involved one patient with no patient consequences.The age and weight of the male patient were not provided.

• Brand Name: REPAIR, WHITE ADAPTER LEG
• 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: 9576326
• Report Number: 3006260740-2020-00041
• Device Sequence Number: 19477565
• Product Code: LJS
• UDI-Device Identifier: 00801741036415
• UDI-Public: (01)00801741036415
• 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,Followup,Followup
• Report Date (Section B): 07/10/2020

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: 0601680
• Device Catalogue Number: 0601680
• Device Lot Number: REBV1679
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 12/31/2019; 03/27/2020; 06/30/2020
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 01/10/2020; 03/27/2020; 07/10/2020
• Patient Sequence Number: 1