MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM DOME IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0602850
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 10/2023).
Event or Problem Description
It was reported that during a port placement, the catheter needle was allegedly broken.The procedure was completed using another port.There was no reported patient injury.
Event or Problem Description
It was reported that during a port placement, the catheter needle was allegedly broken.The procedure was completed using another port.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 titanium dome port, one groshong catheter, one flushing connector, one introducer needle, one straight non-coring needle, one right-angle non-coring needle, one vein pick, two catheter locks, one guidewire in a guidewire hoop, one introducer peel-apart sheath and vessel dilator, one safety infusion set, and one tunneler were returned for evaluation.Gross, microscopic visual and functional testing were performed.The investigation is confirmed for the reported catheter needle break as, multiple cracks were observed on the proximal needle hub.A leak from the needle hub was observed upon infusion of the device; the needle did not fully aspirate water and air was noted within the syringe.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: 10/2023).H11: section a through f ¿ the information provide by bd represents all 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.

• Brand Name: TITANIUM DOME IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• 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: 11010063
• Report Number: 3006260740-2020-20925
• Device Sequence Number: 4496373
• Product Code: LJT
• UDI-Device Identifier: 00801741025754
• UDI-Public: (01)00801741025754
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K880571
• 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): 07/12/2021

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: 0602850
• Device Catalogue Number: 0602850
• Device Lot Number: REDT0903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 07/14/2021
• 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
• Patient Age: 62 DA