MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BROVIAC CV CATHETER, SINGLE-LUMEN, 6.6F; CHRONIC CATHETERS

Model Number	0600544
Medical Device Problem Codes	Fracture (1260); Failure to Infuse (2340); Malposition of Device (2616)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Pneumothorax (2012); Needle Stick/Puncture (2462)
Date of Event	11/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history record will not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that post port device implant, the port was allegedly unable to infuse and as a result the lung was noted to be collapsed and punctured.Upon removal of the device, the device was found to be fractured and as a result embolized the heart.The current status of the patient is unknown.
Event or Problem Description
It was reported through the litigation process that post port device implant, the port allegedly mispositioned and as a result the lung was noted to be collapsed and punctured.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the sample was not returned for evaluation, one medical record was provided for review.The investigation is inconclusive for the reported malposition issue as the exact circumstances at the time of reported event was unknown.However, the investigation is confirmed for the reported pneumothorax issue.According to the medical record, a new 6.6-french single-lumen broviac catheter was tunneled, and the line again was then flushed with saline and ultimately with 5ml of heparin 10 units/ml.On the same day the patient presents with right pneumothorax with intrathoracic line placement.An 8.5 fr pigtail catheter was placed in chest tube for drainage of his lung.Subsequently the prior central line catheter was removed.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.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.

• Brand Name: BROVIAC CV CATHETER, SINGLE-LUMEN, 6.6F
• Common Device Name: CHRONIC CATHETERS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11676799
• Report Number: 3006260740-2021-01355
• Device Sequence Number: 3095750
• Product Code: LJS
• UDI-Device Identifier: 00801741051838
• UDI-Public: (01)00801741051838
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K830256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2021

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: 0600544
• Device Catalogue Number: 0600544
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 09/16/2021
• 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: Life Threatening
• Patient Age: 4 YR
• Patient Weight: 16