MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM LOW-PROFILE IMPLANTABLE PORT, BROVIAC SINGLE-LUMEN, 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0606100
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
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: 12/2024).Device pending return.
Event or Problem Description
It was reported that sometime post port placement, the catheter allegedly ruptured.It was further reported that the patient was transferred to interventional radiology for the removal of catheter under general anesthesia.Reportedly the implantable chamber was removed.The patient current status was unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the first complaint reported to date for this product and lot, therefore a device history record review is not required.Investigation summary: one titanium low profile port attached to a catheter was returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.The investigation is confirmed for the reported catheter rupture and the identified material separation issue, as a complete circumferential break of the catheter was noted inside of the cath-lock.The edges of the break appeared non-uniform and were partially jagged.A definitive root cause could not be determined.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: b5, d4 (expiry date: 12/2024), g3, h6 (device).H11: h6 (patient, 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.H3 other text : see h10.
Event or Problem Description
It was reported that sometime post port placement, the catheter allegedly ruptured.It was further reported that the patient was transferred to interventional radiology for the removal of catheter under general anesthesia.Reportedly, the implantable chamber was removed.The patient experienced pain at the site of the implantable chamber; however, the current status of the patient was unknown.
Event or Problem Description
It was reported that sometime post port placement, the catheter allegedly ruptured.It was further reported that the patient was transferred to interventional radiology for the removal of catheter under general anesthesia.Reportedly, the implantable chamber was removed.The patient experienced pain at the site of the implantable chamber; however, the current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the first complaint reported to date for this product and lot, therefore a device history record review is not required.Investigation summary: one titanium low profile port attached to a catheter was returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.The investigation is confirmed for the reported catheter rupture and the identified material separation issue, as a complete circumferential break of the catheter was noted inside of the cath-lock.The edges of the break appeared non-uniform and were partially jagged.Based upon the available information, the definitive root cause for this event is unknown.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: 12/2024), g3, h6(patient).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.

• Brand Name: TITANIUM LOW-PROFILE IMPLANTABLE PORT, BROVIAC SINGLE-LUMEN, 6.6F
• 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: 11594355
• Report Number: 3006260740-2021-01058
• Device Sequence Number: 19710744
• Product Code: LJT
• UDI-Device Identifier: 00801741026041
• UDI-Public: (01)00801741026041
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0606100
• Device Catalogue Number: 0606100
• Device Lot Number: REER0763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 06/30/2021; 07/15/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 07/07/2021; 07/20/2021
• 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; Required Intervention