MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PP TI ISP 8CF WITH SUTURE PLUGS - BUMPLESS - INTERMEDIATE KIT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	1708160
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported event, the 1708160 pp ti isp 8cf with suture plugs - bumpless - intermediate kit were not returned for direct examination, but an x-ray image was provided.The photo is currently under investigation.Acrum.
Event or Problem Description
This report summarizes four malfunction events.A review of the events indicated that model 1708160 pp ti isp 8cf with suture plugs - bumpless - intermediate kit experienced material deformation.These reports were received from various sources.Of the five events, all involved patients with no reported injuries.The patients ranged from 38 to 77 years of age and weight was not provided.Of the reported patients, two were male and two were female.The 1708160 pp ti isp 8cf with suture plugs - bumpless - intermediate kits were not returned for direct examination, but an x-ray image was provided.The photo is currently under investigation.
Additional Manufacturer Narrative
Two lot numbers were provided, and lot history reviews were performed.No devices were returned for all four malfunctions.Three x-rays and an electronic photo were provided.The investigation is inconclusive for material deformation, for all four malfunctions.A root cause has not been determined.The devices were labeled for single use.
Event or Problem Description
This report summarizes four malfunction events.A review of the events indicated that model 1708160 pp ti isp 8cf with suture plugs - bumpless - intermediate kit experienced material deformation.These reports were received from various sources.Of the five events, all involved patients with no reported injuries.The patients ranged from 38 to 77 years of age and weight was not provided.Of the reported patients, one was male, three were female.The 1708160 pp ti isp 8cf with suture plugs - bumpless - intermediate kits were not returned for direct examination, but x-ray images were provided.

• Brand Name: PP TI ISP 8CF WITH SUTURE PLUGS - BUMPLESS - INTERMEDIATE KIT
• 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: 8533350
• Report Number: 3006260740-2019-01103
• Device Sequence Number: 13855889
• Product Code: LJT
• UDI-Device Identifier: 00801741026676
• UDI-Public: (01)00801741026676
• 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): 07/23/2019

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: No Information
• Device Model Number: 1708160
• Device Catalogue Number: 1708160
• Device Lot Number: RECW1212,RECW1878
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1