MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT DUO M.R.I. IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, 9.5F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	5829502
Medical Device Problem Codes	Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extravasation (1842); Pain (1994); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/08/2021
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: 05/2022.
Event or Problem Description
It was reported that post port device implant within the right internal jugular vein, the patient allegedly experienced pain, swelling, thrombotic thrombocytopenic purpura and extravasation.The current status of the patient is unknown.
Event or Problem Description
It was reported that post port device implant within the right internal jugular vein, the patient allegedly experienced pain, swelling, thrombotic thrombocytopenic purpura (ttp) and extravasation.It was further reported that, the device allegedly leaked the contrast dye next to the port located inside the chest wall.The current status of the patient is unknown.
Additional 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: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported extravasation issue as no objective evidence was provided for review.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.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: b5,d4 (expiry date: 05/2022),g3,h6(method).H11: e3, h6(device, result, 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.

• Brand Name: POWERPORT DUO M.R.I. IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, 9.5F
• 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: 11714672
• Report Number: 3006260740-2021-01497
• Device Sequence Number: 3833127
• Product Code: LJT
• UDI-Device Identifier: 00801741027406
• UDI-Public: (01)00801741027406
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K090512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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: 5829502
• Device Catalogue Number: 5829502
• Device Lot Number: REEV2356
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 07/29/2021
• 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: 48 YR
• Patient Weight: 62