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

Model Number 0604970

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 05/2024).

Event Description

It was reported that during a port placement procedure, the device couldn't attach the catheter to the chamber hub.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one slimport d/l rosenblatt attached to a catheter was returned for evaluation.Visual, microscopic visual and functional evaluation were performed on the returned device.The investigation is inconclusive for the reported loose or intermittent connection issue as the device was returned without cath-lock connected and it is unknown whether cath-lock was connected during the procedure.The definitive root cause could not be determined based upon 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: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.H3 other text : see h10.

Event Description

It was reported that during a port placement procedure, the device couldn't attach the catheter to the chamber hub.There was no reported patient injury.

• Brand Name: SLIMPORT IMPLANTABLE PORT, DUAL-LUMEN ROSENBLATT, 7F
• Type of Device: PORT & CATHETER, IMPLANED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11441255
• MDR Text Key: 238845159
• Report Number: 3006260740-2021-00733
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025884
• UDI-Public: (01)00801741025884
• Combination Product (y/n): N
• PMA/PMN Number: K964066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other