MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SLIMPORT IMPLANTABLE PORT, DUAL-LUMEN ROSENBLATT, 7F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0604970
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 05/2024).
Event or Problem Description
It was reported that some time post placement procedure, the catheter allegedly had droplets when connected to the dual port hub.It was further reported that another catheter was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the third complaint reported for this lot number and the lot met all release criteria.A device history record review is required.Investigation summary: one slimport d/l rosenblatt attached to a d/l catheter in two segments were returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.A complete circumferential break was noted approximately 11.9 cm from the proximal end of the port stem.However, the edges of the complete circumferential break appeared smooth with striations noted on the break surface.The investigation is confirmed for the reported catheter leakage and the identified fracture issue, as a circumferential split was noted just distal to the proximal end of the port stem.The edges of the circumferential split appeared jagged.Necking was noted on 2.4 cm and 4.1 cm from the end of the second catheter segment.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 05/2024).H11: h6 (method, result 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
It was reported that some time post placement procedure, the catheter allegedly had droplets when connected to the dual port hub.It was further reported that another catheter was used to complete the procedure.There was no reported patient injury.

• Brand Name: SLIMPORT IMPLANTABLE PORT, DUAL-LUMEN ROSENBLATT, 7F
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11377003
• Report Number: 3006260740-2021-00477
• Device Sequence Number: 19784158
• Product Code: LJT
• UDI-Device Identifier: 00801741025884
• UDI-Public: (01)00801741025884
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K964066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2021

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: 0604970
• Device Catalogue Number: 0604970
• Device Lot Number: REDW1441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other